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More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
In every interview that you might attend, you always wish to know the questions beforehand. However, you should keep in mind that the panel sitting in front of you is experienced and can go a step higher if you can steer clear from their simple volleys. No list of questions or guide is perfect but they all are for the preparation of better good. We bring forth to you a list of few academic questions that might make the tortuous path a little easier.What is Pharmacovigilance?Pharmacovigilance has been defined by the World Health Organisation (WHO) as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem”2. What are the minimum criteria required for a valid case?An identifiable reporterAn identifiable patientA suspect productAn adverse drug event3. What is an Adverse Drug Event (ADE)?The ICH E2A guideline describes Adverse Events as any “untoward medical occurrence” which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to that person. 4. What is an Adverse Drug Reaction (ADR)?ICH E2A characterizes Adverse Reactions according to the stage of the medicinal product’s life cycle. If the product has not yet been marketed, Adverse Reactions are any “noxious and unintended responses” to the product at any dose. The effect of this classification is to reasonably establish that a relationship between the product and the reaction “cannot be ruled out”. Once the product has been placed in the market, “Adverse Reactions” encompass responses which are again “noxious and unintended” but occur at the established routine dosages which have been defined for use in humans to prevent, diagnose, or treat disease or modify “physiological function”.5. What is the difference between an ADE and ADR?Adverse drug event and adverse drug reaction both are adverse occurrence but if one finds the causality for adverse occurrence its adverse drug reaction and if one fails to find causality for adverse occurrence then it is referred to as adverse drug event.6. What do you mean by causality?Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event.7. When do you consider an event to be serious?If an event is associated with any one of the following, it is considered to be seriousDeathLife threateningHospitalization or prolongation of hospitalization.Congenital anomaly /Birth DefectDisabilityRequiring intervention to prevent permanent damage or impairmentMedically significant8. What is the yellow card in pharmacovigilance?The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman.9.What is informed consent?Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information.10.Name the regulatory bodies in USA, UK, Japan and India?USA: United States Food and drug administration (USFDA).UK: European Medicines Agency (EMEA).Japan: Ministry of Health, Labour and Welfare (MHLW).India: Central Drugs Standard Control Organization (CDSCO)11.What is Volume 9A?Volume 9A brings together “The rules governing medicinal products in the European Union”contains general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorisation Holders and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH). With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency.12.What do the different part of Volume 9A deal with?Part I deals with Guidelines for Marketing Authorisation Holders;Part II deals with Guidelines for Competent Authorities and the Agency;Part III provides the Guidelines for the electronic exchange of pharmacovigilance in the EUPart IV provides Guidelines on pharmacovigilance communication.13. Difference between NDA and ANDA?NDA means New Drug Application. When the sponsor of the new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application.ANDA means Abbreviated New Drug Application. It contains data that, when submitted to FDA, provides for the review and ultimate approval of a generic drug product.14.What are the phases of clinical trials?Phase I studies assess the safety of a drug or device. Phase II studies test the efficacy of a drug or device.Phase III studies involve randomized and blind testing in several hundred to several thousand patients. Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale.15. What do you mean by MedDRA?Medical Dictionary for Regulatory Activities.16.Explain the hierarchy in MedDRA.System Organ Class (SOC)High Level Group Term (HLGT)High Level Term (HLT)Preferred Term (PT)Lower Level Term (LLT)17. AbbreviationsSUSARSuspected Unexpected Serious Adverse ReactionSAESerious Adverse EventCIOMSCouncil for International Organizations of Medical SciencesADEAdverse Drug EventSSARSuspected Serious Adverse ReactionADRAdverse Drug ReactionICSRIndividual Case Safety ReportPSURPeriodic Safety Update ReportICHInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)HIPAAHealth Insurance Portability and Accountability ActESTRIElectronic Standards for the Transfer of Regulatory InformationIBDInternational Birth Date18. What do you know about E2a, E2b and E2c guidelines?E2A Clinical Safety Data Management: Definitions and Standards for Expedited ReportingE2B (R2) Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety ReportsE2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety ReportsE2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsE2C (R2) Periodic Benefit-Risk Evaluation Report19.What is IND approval?The United States Food and Drug Administration’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.20.What is EudraVigilance?The European Union data-processing network and management system, established by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports related to all medicinal products authorised in the European Economic Area (EEA). EudraVigilance also incorporates data analysis facilities.21. What are the types of Pharmacovigilance (PV)? Two types. 1. Active PV and 2.Passive PVActive PV: Active (or proactive) safety surveillance means that active measures are taken to detect adverse events. This is managed by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records.Passive PV: Passive surveillance means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns.22.What are the due dates for safety reporting?Safety reporting due dates are 7 days for IND Reporting and 15 days for NDA Reporting23.What is inverted Black triangle in Pharmacovigilance?A black triangle appearing after the trade name of a British medicine indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration.The black triangle also highlights the need for surveillance of any adverse drug reaction (ADRs) that might arise from the use of a new medication.24.What is Pharmacovigilance Programme of India (PvPI)?The Central Drugs Standard Control Organisation (CDSCO), New Delhi has initiated a nation-wide pharmacovigilance programme under the aegis of Ministry of Health & Family Welfare, Government of India. The programme is coordinated by The Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. The National Coordinating Centre (NCC) is operating under the supervision of Steering Committee to recommend procedures and guidelines for regulatory interventions in India.25.What is a signal?A ‘signal’ consists of reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
In every interview that you might attend, you always wish to know the questions beforehand. However, you should keep in mind that the panel sitting in front of you is experienced and can go a step higher if you can steer clear from their simple volleys. No list of questions or guide is perfect but they all are for the preparation of better good. We bring forth to you a list of few academic questions that might make the tortuous path a little easier.What is Pharmacovigilance?Pharmacovigilance has been defined by the World Health Organisation (WHO) as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem”2. What are the minimum criteria required for a valid case?An identifiable reporterAn identifiable patientA suspect productAn adverse drug event3. What is an Adverse Drug Event (ADE)?The ICH E2A guideline describes Adverse Events as any “untoward medical occurrence” which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to that person. 4. What is an Adverse Drug Reaction (ADR)?ICH E2A characterizes Adverse Reactions according to the stage of the medicinal product’s life cycle. If the product has not yet been marketed, Adverse Reactions are any “noxious and unintended responses” to the product at any dose. The effect of this classification is to reasonably establish that a relationship between the product and the reaction “cannot be ruled out”. Once the product has been placed in the market, “Adverse Reactions” encompass responses which are again “noxious and unintended” but occur at the established routine dosages which have been defined for use in humans to prevent, diagnose, or treat disease or modify “physiological function”.5. What is the difference between an ADE and ADR?Adverse drug event and adverse drug reaction both are adverse occurrence but if one finds the causality for adverse occurrence its adverse drug reaction and if one fails to find causality for adverse occurrence then it is referred to as adverse drug event.6. What do you mean by causality?Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event.7. When do you consider an event to be serious?If an event is associated with any one of the following, it is considered to be seriousDeathLife threateningHospitalization or prolongation of hospitalization.Congenital anomaly /Birth DefectDisabilityRequiring intervention to prevent permanent damage or impairmentMedically significant8. What is the yellow card in pharmacovigilance?The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman.9.What is informed consent?Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information.10.Name the regulatory bodies in USA, UK, Japan and India?USA: United States Food and drug administration (USFDA).UK: European Medicines Agency (EMEA).Japan: Ministry of Health, Labour and Welfare (MHLW).India: Central Drugs Standard Control Organization (CDSCO)11.What is Volume 9A?Volume 9A brings together “The rules governing medicinal products in the European Union”contains general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorisation Holders and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH). With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency.12.What do the different part of Volume 9A deal with?Part I deals with Guidelines for Marketing Authorisation Holders;Part II deals with Guidelines for Competent Authorities and the Agency;Part III provides the Guidelines for the electronic exchange of pharmacovigilance in the EUPart IV provides Guidelines on pharmacovigilance communication.13. Difference between NDA and ANDA?NDA means New Drug Application. When the sponsor of the new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application.ANDA means Abbreviated New Drug Application. It contains data that, when submitted to FDA, provides for the review and ultimate approval of a generic drug product.14.What are the phases of clinical trials?Phase I studies assess the safety of a drug or device. Phase II studies test the efficacy of a drug or device.Phase III studies involve randomized and blind testing in several hundred to several thousand patients. Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale.15. What do you mean by MedDRA?Medical Dictionary for Regulatory Activities.16.Explain the hierarchy in MedDRA.System Organ Class (SOC)High Level Group Term (HLGT)High Level Term (HLT)Preferred Term (PT)Lower Level Term (LLT)17. AbbreviationsSUSARSuspected Unexpected Serious Adverse ReactionSAESerious Adverse EventCIOMSCouncil for International Organizations of Medical SciencesADEAdverse Drug EventSSARSuspected Serious Adverse ReactionADRAdverse Drug ReactionICSRIndividual Case Safety ReportPSURPeriodic Safety Update ReportICHInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)HIPAAHealth Insurance Portability and Accountability ActESTRIElectronic Standards for the Transfer of Regulatory InformationIBDInternational Birth Date18. What do you know about E2a, E2b and E2c guidelines?E2A Clinical Safety Data Management: Definitions and Standards for Expedited ReportingE2B (R2) Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety ReportsE2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety ReportsE2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsE2C (R2) Periodic Benefit-Risk Evaluation Report19.What is IND approval?The United States Food and Drug Administration’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.20.What is EudraVigilance?The European Union data-processing network and management system, established by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports related to all medicinal products authorised in the European Economic Area (EEA). EudraVigilance also incorporates data analysis facilities.21. What are the types of Pharmacovigilance (PV)? Two types. 1. Active PV and 2.Passive PVActive PV: Active (or proactive) safety surveillance means that active measures are taken to detect adverse events. This is managed by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records.Passive PV: Passive surveillance means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns.22.What are the due dates for safety reporting?Safety reporting due dates are 7 days for IND Reporting and 15 days for NDA Reporting23.What is inverted Black triangle in Pharmacovigilance?A black triangle appearing after the trade name of a British medicine indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration.The black triangle also highlights the need for surveillance of any adverse drug reaction (ADRs) that might arise from the use of a new medication.24.What is Pharmacovigilance Programme of India (PvPI)?The Central Drugs Standard Control Organisation (CDSCO), New Delhi has initiated a nation-wide pharmacovigilance programme under the aegis of Ministry of Health & Family Welfare, Government of India. The programme is coordinated by The Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. The National Coordinating Centre (NCC) is operating under the supervision of Steering Committee to recommend procedures and guidelines for regulatory interventions in India.25.What is a signal?A ‘signal’ consists of reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
General questionsMany hiring managers begin interviews by asking a series of general questions designed to get to know your personality. Review these commonly asked preliminary questions before your next interview:What do you see yourself doing in five years?Why do you want to work for this company?How did you become interested in working as a medical scribe?How would your previous colleagues or classmates describe you?What are your hobbies?What are your strengths?In what areas are you hoping to improve?What do you know about our organization?What are your hours of availability? Are you able to work evenings, nights and weekends?What are your long-term career goals?Questions about experience and backgroundMedical scribes must have certain training and experience to perform their role effectively. Hiring managers often ask questions related to education and qualifications to determine if you're the right person for the role. Here are some common questions about experience and background:How many words per minute can you type?How is your typing accuracy?Where did you go to school?Are you familiar with shorthand?What professional development are you interested in pursuing?How is your spelling? Do you struggle to accurately record any medical terminology?Do you have experience working as a medical scribe?What skills do you have that qualify you to work as a medical scribe?Do you have particular training or interest in a medical specialty?What do you hope to learn from your time as a medical scribe?In-depth questionsMedical scribes should be ready to multitask and handle time-sensitive information and situations in the course of their work. Hiring managers usually ask problem-solving questions related to the responsibilities of a medical scribe to see how you handle challenges. Consider these in-depth questions:How would you handle the loss of a patient on the job?Define a few of the most common medical terms you encounter in your role.Your patient vomits or begins bleeding during your work duties. How do you handle the situation?Please spell hyperglycemia.Do you understand HIPAA laws? How do they impact your work?What healthcare software are you familiar with?Your computer malfunctions while taking notes for a doctor. What do you do?What do you think is most challenging about working as a medical scribe?Why is professionalism so important for medical scribes?Describe how you would write notes for a doctor during an examination.Describe the relationship between the attending physician and the medical scribe.Interview questions with sample answersHiring managers often ask medical scribe candidates a series of predictable questions during the interview. Knowing why they're asking the question and how to answer it can help you respond confidently and accurately. Here are a few common interview questions with explanations and sample answers to help you prepare:How would you handle the situation if your attending physician finds an error in your notes?What questions would you ask when intaking a new patient to get their medical background?What do you know about the requirements of the position?How do you handle stress?How important is patient communication for you?How would you handle the situation if your attending physician finds an error in your notes?Working as a medical scribe often entails substantial focus and attention to detail with patients dealing with physical or emotional pain and time pressure. Mistakes can happen during note-taking, so hiring managers want to know how you'll handle these situations in advance of making a hiring decision.Example: "I take extreme care when scribing for physicians during high-pressure examinations or treatment. I know that mistakes can still happen.Should a physician find an error in my notes, I would want to know what type of error it was—whether it be spelling, grammar, incorrect information or something else—so I can remedy the situation in the future. I would apologize for my mistake and ask if there's anything I can do to improve for my next assignment."What questions would you ask when intaking a new patient to get their medical background?Some medical scribes meet with patients for routine visits before the doctor to take a medical history. Hiring managers want to ensure that you know what questions to ask and how to ask them to maintain a positive relationship with the patient.Example: "If I needed to take a patient's medical history, I would first check to see why they were visiting the office. Usually, the questions we ask are somewhat related to the visit. Regardless of the reason for the visit, I would ask for their name, date of birth and if they had any current pain. I would ask about previous surgeries or conditions and family history that might be relevant to their care."What do you know about the requirements of the position?A medical scribe's duties can vary tremendously depending on the office or organization. Hiring managers might ask you what you know about the position to see what research you did before the interview and to gauge your understanding of what a medical scribe generally does.Example: "I understand that this medical scribe position is for the emergency room. I'm prepared to work any shifts necessary, including nights and weekends. I know my doctor might task me with a variety of responsibilities, from patient intake to assisting with exam or procedure note-taking. I'm ready to work in a fast-paced environment and multitask as needed."How do you handle stress?Medical scribes might work with patients facing pain or confusion or in high-pressure, time-sensitive situations, all of which can increase stress. Hiring managers will want to be sure you're aware of the possible stressors of the position and know how to handle these situations should they arise.Example: "I know that there can be moments of high stress when working as a medical scribe. Since I've worked in the position before, I feel confident I can manage stressful situations with a few coping strategies. First, I use deep breathing to slow my heart rate and help me focus on the task at hand. I ask for assistance when I need it to ensure I'm getting all the necessary information recorded. Finally, I stay aware of my surroundings so that if an emergency arises I can quickly get myself and my equipment out of the way to support patient care."How important is patient communication for you?Medical scribes may or may not communicate directly with patients, depending on the specifics of their role. However, hiring managers want to ensure you'll respect and listen to patients whenever you're in proximity to them.Example: "It's imperative that patients feel comfortable and heard while in a medical facility. I'll do my best to answer questions and reassure patients as needed during their time with me."
More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
Tell me about yourself.What are your strengths?What are your weaknesses?Why do you want this job?Where would you like to be in your career five years from now?What's your ideal company?What attracted you to this company?Why should we hire you?What did you like least about your last job?When were you most satisfied in your job?What can you do for us that other candidates can't?What were the responsibilities of your last position?Why are you leaving your present job?What do you know about this industry?What do you know about our company?Are you willing to relocate?Do you have any questions for me?
More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
What was the last project you led, and what was its outcome?Give me an example of a time that you felt you went above and beyond the call of duty at work.Can you describe a time when your work was criticized?Have you ever been on a team where someone was not pulling their own weight? How did you handle it?Tell me about a time when you had to give someone difficult feedback. How did you handle it?What is your greatest failure, and what did you learn from it?How do you handle working with people who annoy you?If I were your supervisor and asked you to do something that you disagreed with, what would you do?What was the most difficult period in your life, and how did you deal with it?Give me an example of a time you did something wrong. How did you handle it?Tell me about a time where you had to deal with conflict on the job.If you were at a business lunch and you ordered a rare steak and they brought it to you well done, what would you do?If you found out your company was doing something against the law, like fraud, what would you do?What assignment was too difficult for you, and how did you resolve the issue?What's the most difficult decision you've made in the last two years and how did you come to that decision?Describe how you would handle a situation if you were required to finish multiple tasks by the end of the day, and there was no conceivable way that you could finish them.
More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
How would you describe your work style?What would be your ideal working environment?What do you look for in terms of culture—structured or entrepreneurial?Give examples of ideas you've had or implemented.What techniques and tools do you use to keep yourself organized?If you had to choose one, would you consider yourself a big-picture person or a detail-oriented person?Tell me about your proudest achievement.Who was your favorite manager and why?What do you think of your previous boss?Was there a person in your career who really made a difference?What kind of personality do you work best with and why?What are you most proud of?What do you like to do?What are your lifelong dreams?What do you ultimately want to become?What is your personal mission statement?What are three positive things your last boss would say about you?What negative thing would your last boss say about you?What three character traits would your friends use to describe you?What are three positive character traits you don't have?If you were interviewing someone for this position, what traits would you look for?List five words that describe your character.Who has impacted you most in your career and how?What is your greatest fear?What is your biggest regret and why?What's the most important thing you learned in school?Why did you choose your major?What will you miss about your present/last job?What is your greatest achievement outside of work?What are the qualities of a good leader? A bad leader?Do you think a leader should be feared or liked?How do you feel about taking no for an answer?How would you feel about working for someone who knows less than you?How do you think I rate as an interviewer?Tell me one thing about yourself you wouldn't want me to know.Tell me the difference between good and exceptional.What kind of car do you drive?There's no right or wrong answer, but if you could be anywhere in the world right now, where would you be?What's the last book you read?What magazines do you subscribe to?What's the best movie you've seen in the last year?What would you do if you won the lottery?Who are your heroes?What do you like to do for fun?What do you do in your spare time?What is your favorite memory from childhood?
More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
Q. Tell me about yourselfAns: Start with something like that, My name is Sanjay, and I am a pharma graduate, I completed my Degree from (college name) in a (year). My father is a farmer and my mother is a Housewife.Q. What do you know about our company?Ans: Tell them about the company’s history, direction, progress, culture, and products.Q. Tell me about your strength.Ans: Tell them about your Strenth so that they can answer like Supportive, or Diplomatic. Good communication, Pressure handling, truthness, creativity, well organizer, willpower, dedication, and motivation.Q. What is your weakness?Ans: You can tell them about your weakness like if you have in followings:I sometimes lack overconfidentI have trouble asking for helpI focused too much on details so its consumed lots of time.Q. Why should we hire you?Ans:I can do the work and deliver good results within the time frameworkI can manage a team or work as a team to grow moreI have skills like soft skills, and technical skills, perform multiple tasks at onceEducation and training deliverQ. Are you a hard worker or a smart worker?Ans: Sir, basically I am a hard worker, but now I can complete the project by doing hard work within the time frame.Q. What are your salary expectations?Ans: As a fresher, I expect the salary as per company norms or policyTop Pharma Interview Questions Production for fresherQ. Why do you want to join Production?Ans: As I am capable to work in any environment, I can handle pressure. I am also interested in manufacturing activities.Q. What are the different types of tablets in pharma?Ans:Coated tabletsUncoated tabletsEffervescence tabletsLong release tabletsModified-release tabletsSugar-coated tabletsEnteric-coated tabletsDispersible tabletsQ. What is GMP stand for?Ans: GMP Stands for good manufacturing practices.Q. Who is cGMP?Ans: Current good manufacturing practices.Q. What are capsules in dosage form?Ans: The capsule may be in granules, powder, and semi-solid form.Q. Describe the types of capsules?Ans: Capsules are of two types: Hard gelatin capsules and soft gelatin capsules.Q. What is packing in pharmaceuticals and their types?Ans: Packing is the enclosed envelopes of the medicament in the form of strips, blisters, and bottles.Q. Types of packing in pharmaceuticals?Ans: There are basically three types of packaging in pharmaPrimary packingSecondary packingTertiary packingQ. What is Primary Packing?Ans: Primary packing mainly involves enclosing the medication inside the pocket or cavity to prevent the medicine from external environments.Q. What is secondary Packing?Secondary packing is used for aggregation purposes either by packing in cartons or slives to get good distribution practice.Q. What is tertiary packing?Ans: Tertiary packing is mainly packing the bundles of medicine in corrugated boxes to prevent the drugs from damage during transport, and also from external or physical damage.Q. What is the difference between disintegration and dissolution?Ans: Disintegration is the process by which an oral dose form breaks down into smaller aggregates. (The ‘break-up time of a solid dosage form is called disintegration time.)Dissolution, on the other hand, is the process by which a solid substance dissolves in a solvent to produce a solution. The affinity between the solid substance and the liquid is what controls it.Q. What is room temperature?Ans: The room temperature is 25°CPharma interview questions and answers pdf will be provided shortly.
More detailsPublished - Mon, 05 Dec 2022
Created by - Admin s
Clinical data management (CDM) is performed by clinical data managers. They conduct clinical research that results in high-quality, statistically sound data and reliable clinical trials. The primary role of clinical data managers is to ascertain that the collection, availability, and integration of data are of acceptable cost and quality.Clinical data management has massive career development, and the people in this position experience tremendous career development. You should aspire for this position and experience the advantages of this massive career development. Here are clinical data management interview questions and answers you need to practice in order to pass your next interview.1. What Is Meant by Masking or Blinding?In masking or blinding, a researcher hides the details from the research subject, even if the research subject is receiving a placebo, investigational product, or current standard treatment. There are two types of binding: Single and double binding. Single binding is where the patient is unaware of the treatment while double binding, neither the patient nor the researcher knows the treatment. Masking or binding helps eliminate biases in the treatment process that the researcher is investigating.2. What is Placebo?Placebo refers to a powder, pill, or liquid that has no active ingredients. Placebo helps researchers to isolate the study treatment effect. They are a significant part of clinical studies. They give researchers a comparison point for new therapies to prove if they are effective and safe. Additionally, they provide the clinical data managers with the evidence they need to use to regulatory bodies to approve a new drug.3. What is a Patient File? What Information Does It Contain?A patient’s file contains the medical and treatment history of the patient and demographic data. It can also have paper records or a combination of both computer and paper records. The patient file is significant for the continuity of care for the patients. It’s also essential for defending a complaint or clinical negligence claim.4. Define the Different Phases of Clinical TrialsThere are four major clinical trial phases and include:Phase I: Human pharmacology trialsPhase II: Therapeutic exploratory trialsPhase III: Therapeutic confirmatory trialsPhase IV: Post-marketing surveillance trialsPhase I trials take one or more years and test one or more combinations of objectives. It also includes MAD, SAD, and food effect studies. Phase II trials last for one or two years and test the effective dose and the dosing regimen. Phase III trials range from 3 to 5 years and are called randomized, controlled, and multicenter trials and are significant for the approval of drugs. Phase IV trials are those that the regulatory authorities require the manufacturer to take for competitiveness.5. What are Orphan Trials?Orphan trials are tests that the clinical manager performs on drugs designed to treat diseases that affect less than 200,000 people. They carry out the test on a small number of extremely sick people and see if the drugs work immediately.6. What is Bioequivalence?Bioequivalence is where the clinical manager evaluates the anticipated in-vivo biological equivalence of two proprietary preparation of drugs. Two drugs are bioequivalent if they are for the same intent and purpose. Bioequivalence is very significant in the development of pharmaceuticals. It matches the set standards to ensure the therapeutic performance of the drug that has undergone several processes from manufacturing until it reached the market is good.7. What Causes the Different Phases of Trials to Fail?Phase I trial fails when the pre-clinical model isn’t equivalent to human behavior, or there is insufficient pre-clinical data or extra toxic drug in humans. It can also fail when there is a shift in drug formulation from pre-clinical testing to clinical testing. Phase II and III trial fails due to drug interaction, drug-disease interaction, economic, infrequent ADRs and insufficient effectiveness.8. What Does the Declaration of Helsinki State?The Helsinki declaration describes the rules for research, clinical care, and non-therapeutic research. The rules are that:Risk should never outdo benefitsOnly medically scientifically qualified individuals should conduct researchResearchers should base research on human beings on the results from animal and laboratory experimentsIndependent committee should review research protocols before initiation9. What are the Objectives of IchThe primary goal of Ich is to give recommendations on various ways to attain greater harmonization in the application and interpretation of technical guidelines and requirements for product registration. It aims at reducing the need to duplicate the tests conducted during the research and development of new medicines.10. What are the Participants of Pharmacovigilance?The participants include patients, doctors, nurses, pharmaceutical companies, and importing and distributing companies. The patients are the core consumers of the medicine. Doctors, nurses, and other health care practitioners are responsible for monitoring the safety standards of the medicines.11. What is the Importance of Pharmacovigilance?Pharmacovigilance is important in limiting the illegal sale of medicines and drugs of abuse over the internet. It also curbs increased self-medication, and increased use of traditional medication outside the borders of traditional practices use. Besides, pharmacovigilance reduces the increased use of different system medications with the potential for drug interaction.12. What is Ib?The investigator brochure (Ib) is a primary document which the clinical manager needs for clinical trials concerning FDA regulations. Ib contains:The formulation and description of the drug substance.Summary of the toxicological and pharmacological effects.Summary of information relating to its safety and effectiveness in humansDescribes the adverse reaction and possible risks a patient should expect and the investigator’s precautions.13. What is Protocol Document?A protocol document defines the objectives, methodology, design, statistical considerations, and clinical trial organization. It permits researchers at multiple locations to research in the same manner to allow a combination of their data as if they did the study in the same location. Moreover, the protocol document gives the research administrators and the local researchers a common reference document for their roles during the trial.14. What is an Audit Trail?The audit trail refers to the data that shows the study was carried out following the accepted protocols. It mentions who, why, and when the changes in the data take place. It can also be referred to as documentation that permits the reconstruction of the course of events, according to the Society for Clinical Data Management (SCDM). Audit trails are vital in ensuring visibility in developing a system to an accurate review of the historical security and ensures the information is secure and can’t get in the hands of unauthorized personnel.15. Describe the Process of Discrepancy ResolutionThe discrepancy management team resolves the discrepancy resolution using Data Clarification Form (CDF) or the Data Query Form (DQF). The team generates DCF and sends it to the site investigator for clarification. The investigator receives the corrected values as a response to the CDF and updates them in the database. Lastly, the investigator locks the database to prevent further unauthorized modifications after he has crosschecked the data for errors.16. What Are the Roles of Clinical Data Manager?A clinical data manager collects data from numerous medical research projects like clinical and pharmaceutical trials. He/she collaborates with the team members to ensure they collect data, manage and give clear reports that are accurate and secure.17. What Are the Qualities That a Clinical Data Manager Should Possess to Be EffectiveAn excellent clinical data manager should have excellent written and verbal communication skills to communicate effectively with the other researchers and record the data accurately. Additionally, he needs to have computer skills, database skills, and project management skills to ensure the project runs smoothly and accomplishes its objectives.18. How Do You Stay Motivated at Work?I value people’s health, and I love it when people get clinically proven medicines that effectively improve their health. Clinical data management is a very significant phase in clinical research and results in high-quality, statistical, sound data that is reliable from clinical trials. I get motivated to work hard to reduce the time from drug development to marketing to ensure those ailing can get the medications on time.19. Describe Your Daily Routine as a Clinical Data ManagerI start my day by processing clinical data such as receipts, verifications, entry, and filing of information. I oversee the work that the data management project staff handle and develop data questions based on validation checks or errors and omissions that I identified during data entry and resolve the problems.20. Describe a Time You Failed in This Role and The Lessons You LearnedAs a clinical data manager, I had poor trials and inconsistencies with my endpoints during my first project. The poor trials were because I didn’t plan effectively on goals for the entire development phase, including post-market. Additionally, I involved a biostatistician and consultant statistician towards the end of the project and not from the initial stage. However, I learned to plan effectively and involve the right biostatistician and the consultant statistician from the onset of the project as they play a critical role in protocol development, monitoring and reporting, and data management.21. Why are You Interested in This Role?I have always admired working in your company. I thus follow all your social media handles and read all your posts. I know all the rules and regulations of your company, and I like the way you manage the company and how you support your employees. I want to be part of your team, and I promise to work smart and collaborate with my team members to ensure the success of the projects we handle.22. What Challenges Did You Face During Your Last Role? How Did You Handle It?The major challenge was the shortage of data for testing. It’s very dangerous to test with real-time data, and it’s against privacy regulations. Our company had insufficient realistic information that we needed for testing purposes. The shortage led to the delay in the production of the medicine. Thus, I talked to the company manager, and we purchased a reliable automated software for test data generation that helped us create fictitious test data credentials effectively.23. Describe Briefly About Your Clinical Data Management ExperienceI have over fifteen years of experience as a clinical data manager. I started working as a clinical manager in a hospital in town where I worked for six years, then got a transfer to work in their new branch in a new town. I have gained numerous skills such as project management skills, database skills, computer skills, and excellent communication skills throughout my working experience. I am conversant with all the methods of collecting data, preparing, and distributing while following the legal legislations.24. What Kind of Strategy and Mindset is Required for This Role?A clinical data manager needs to have excellent project management and communication skills to ensure the projects succeed. He/she should have a positive mindset and be willing to collaborate with team members and learn from them. He/she should set clear objectives to determine the process, governance tools, etc. The clinical data manager should also create strong data processors such as collection process, preparation, storage, and data distribution. Additionally, he/she should determine the right technology to store the data and ensure safety. 25. What is the Biggest Challenge You Foresee in This Job?The biggest challenge is usually a lack of cooperation from team members, which can cause a testing project to fail. That can lead to data breaches, and also unintended data which could be costly. The malicious activities could result in a financial dent in an organization and lead to serious legal implications. However, various data masking and de-identification solutions have come up to help clinical data managers build safe test environments and comply with the regulations. Thus, I anticipate no challenge while working in your organization.ConclusionClinical data management is a great role with a lot of advantages. According to PayScale, the salary of a clinical data manager averages around $77,401 per year. You can’t afford to miss an opportunity with such an amazing salary. Study and practice these interview questions and answers to be adequately prepared for your clinical data management interview.
More detailsPublished - Mon, 05 Dec 2022
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