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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
1. Can you explain your experience with clinical trial data analysis? Answer: I have X years of experience in performing clinical trial data analysis, utilizing statistical software such as SAS and R to manage, clean, and analyze large datasets. I have worked on various phases of clinical trials and have experience in creating and implementing statistical analysis plans (SAPs).2. How do you approach designing and implementing statistical analysis plans? Answer: I follow a systematic approach to designing and implementing SAPs. First, I review the protocol and study objectives to ensure a clear understanding of the trial design and data requirements. Next, I determine the appropriate statistical methods and models for the analysis, taking into consideration factors such as sample size and type of data. Finally, I work with the study team to finalize the SAP, incorporating any necessary revisions and ensuring that the plan is in line with regulatory guidelines.3. Can you walk us through your experience with data management and database design? Answer: I have extensive experience in data management, including database design and implementation, data quality control and assurance, and data cleaning and transformation. I have worked with various EDC systems and have implemented data transfer processes to ensure accuracy and completeness of data.4. How do you ensure data quality and accuracy in your analysis? Answer: I follow best practices in data quality control and assurance, including performing data checks and validations, handling missing data appropriately, and monitoring data trends. I also collaborate with study teams and data management groups to resolve any data issues and ensure data accuracy and completeness.5. Can you discuss a complex data analysis project you have worked on and the results obtained? Answer: One example of a complex data analysis project I worked on was a multi-center, randomized clinical trial for a new drug for treatment of a specific disease. I was responsible for designing and implementing the SAP, managing the database, and performing the statistical analysis. The results showed a significant improvement in the treatment arm compared to the control arm, and the findings were published in a peer-reviewed journal.6. Have you worked with electronic data capture (EDC) systems and databases?Answer: Yes, I have extensive experience working with EDC systems and databases. I have worked with various EDC platforms, including [insert specific EDC systems used], and have expertise in designing and implementing databases for clinical trials.7. How do you stay current with advancements in clinical data analysis techniques and tools? Answer: I actively stay up-to-date with the latest advancements in clinical data analysis by attending conferences, workshops, and training sessions. I also regularly review relevant literature and industry publications and collaborate with other clinical data analysts and biostatisticians to exchange ideas and best practices.8. Can you explain how you handle missing data in clinical trials and the impact on analysis results?Answer: I follow established best practices for handling missing data, such as using multiple imputation techniques or performing sensitivity analyses. The approach taken depends on the specific study design, data structure, and missing data pattern. It is important to handle missing data appropriately to ensure that the analysis results are unbiased and accurately reflect the study population.9. Can you discuss your experience with using SAS or other statistical software for clinical data analysis? Answer: I have extensive experience using SAS for clinical data analysis. I have used SAS to perform various types of analyses, including descriptive statistics, inferential statistics, and survival analysis. I am proficient in programming and have also used other statistical software such as R for data analysis.
More detailsPublished - Mon, 30 Jan 2023
Created by - Admin s
Here is a general guide for a Pharmaceutical Quality Assurance (QA) job interview:1. Research the company and industry: Familiarize yourself with the company’s mission, values, products, and services. Also, brush up on the latest industry news and regulations.2. Prepare for common interview questions: You may be asked about your previous experience in QA, your knowledge of Good Manufacturing Practices (GMPs), your problem-solving skills, and your attention to detail.3. Review job description and requirements: Make sure you understand the responsibilities of the role and what qualifications are required.4. Prepare your resume and cover letter: Make sure they highlight your relevant experience and education.5. Show your passion for the field: Emphasize your interest in quality assurance and your commitment to ensuring that products meet regulatory standards.6. Highlight your experience: Share examples of projects you have worked on, challenges you have faced, and how you addressed them.7. Ask questions: Show that you are interested in the company and the role by asking informed questions about the company culture, the department, and opportunities for growth.8. Dress professionally: Make a good first impression by dressing appropriately for the interview.9. Be prepared to discuss your salary expectations: It is important to have a clear understanding of your salary expectations before the interview.Overall, the key to success in a Pharmaceutical QA job interview is to demonstrate your knowledge, passion, and commitment to the field.
More detailsPublished - Fri, 03 Feb 2023
Created by - Admin s
Here are some common interview questions for a position at Teva Pharmaceuticals and tips for answering them:1. What attracted you to Teva Pharmaceuticals?Answer: Research the company prior to the interview and discuss your appreciation for Teva's mission, values, and commitment to improving patient lives.2. Can you describe your experience working in the pharmaceutical industry?Answer: Discuss any relevant experience you have in the industry, including your responsibilities and achievements. Emphasize your ability to work effectively in a fast-paced, high-pressure environment.3. How do you approach problem-solving in your work?Answer: Provide examples of challenges you have faced in your previous positions and describe the steps you took to resolve them. Discuss your ability to analyze information, consider different options, and make decisions quickly.4. Can you describe your experience with Good Manufacturing Practices (GMP) and regulatory compliance? Answer: Discuss your knowledge of cGMP and other relevant regulations and standards, and provide examples of how you have ensured compliance in your previous positions.5. How do you handle change and uncertainty in your work?Answer: Discuss your ability to adapt to changing circumstances, to work effectively under pressure, and to handle ambiguity and uncertainty. Provide examples of how you have successfully navigated change in the past.6. Can you describe a time when you had to work with a cross-functional team?Answer: Provide examples of successful collaboration with cross-functional teams, emphasizing your ability to communicate effectively, to negotiate and resolve conflicts, and to drive results.7. Why should we hire you?Answer: Summarize your skills, experience, and qualifications that make you a strong fit for the role and for Teva Pharmaceuticals. Emphasize how your unique abilities and perspective can contribute to the company's success.
More detailsPublished - Fri, 03 Feb 2023
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