Sankara Nethralaya Pharmacovigilance Analyst Interview: Rounds, Questions and Preparation

What the job involves

A Pharmacovigilance Analyst monitors, assesses, and reports adverse events and other safety information for drugs, biologics, and medical devices. In a healthcare or pharma setting, the day-to-day work involves case intake, data entry into safety databases, coding with MedDRA, writing narratives, and ensuring timely submissions to regulatory authorities. At smaller or fast-growing employers, analysts often handle multiple product types and interact closely with clinical, regulatory, and quality teams.

Role and Technical Knowledge

1. 1

   What is the difference between an adverse event and an adverse drug reaction?

   An adverse event is any untoward medical occurrence after exposure to a drug, whether or not causally related. An adverse drug reaction is a response to a drug that is noxious and unintended, with a reasonable possibility of causal relationship.

2. 2

   What are the four minimum criteria for a valid ICSR?

   An identifiable patient, an identifiable reporter, a suspect product, and an adverse event. Mention that all four are needed for a case to be considered valid for reporting.

3. 3

   Explain the terms seriousness and expectedness in pharmacovigilance.

   Seriousness is based on patient outcomes such as death, hospitalization, disability, congenital anomaly, or life-threatening events. Expectedness compares the event to the reference safety information, such as the investigator brochure or product label.

4. 4

   What is MedDRA and why is it used in case processing?

   MedDRA is a standardized medical dictionary for regulatory activities. It allows consistent coding of adverse events at the preferred term and system organ class levels, which supports analysis and regulatory submissions.

Practical Scenarios and Case Handling

1. 5

   A patient reports dizziness and vomiting after starting a new antihypertensive. How would you process this case?

   Describe the steps: collect patient and reporter details, identify the suspect drug and concomitant medications, record the events with start and stop dates, assess seriousness and causality, code with MedDRA, write a narrative, and submit within the applicable timeline.

2. 6

   How do you decide if a case is serious or non-serious and what timelines apply?

   Apply the seriousness criteria strictly. For serious and unexpected suspected adverse reactions, expedited reporting timelines apply, often 15 calendar days for initial reports and follow-ups. Non-serious cases are usually reported in periodic aggregate reports.

3. 7

   What would you do if you noticed a missing follow-up information in a case you are processing?

   Document the missing information, attempt follow-up with the reporter as per standard operating procedures, and record all attempts. Do not delay the initial report if the case already meets validity and reporting criteria.

4. 8

   How would you handle a case where the reporter is a consumer and the information is incomplete?

   Treat consumer reports as valid if the four minimum criteria are met. Document the gaps, try to obtain follow-up, and code what is available. Escalate to a senior if the case is serious and critical data is missing.

Regulatory and Quality Awareness

1. 9

   What is the role of CDSCO in pharmacovigilance in India?

   CDSCO is the national regulatory authority for drugs and medical devices in India. It oversees the Pharmacovigilance Programme of India and sets requirements for adverse event reporting and periodic safety update reports.

2. 10

   What are the key differences between a PSUR and a PBRER?

   A PSUR is a periodic safety update report with a focus on interval safety data. A PBRER is a more structured benefit-risk evaluation that replaced the PSUR format in many regions, with defined sections on safety, efficacy, and benefit-risk analysis.

3. 11

   Why is Good Documentation Practices important in pharmacovigilance?

   It ensures data integrity, traceability, and audit readiness. Every entry should be attributable, legible, contemporaneous, original, and accurate, with corrections made transparently.

4. 12

   What is signal detection and how is it done?

   Signal detection is the process of reviewing individual case reports and aggregate data to identify new or changing safety concerns. It can use qualitative review and quantitative methods such as disproportionality analysis.

Behavioural and HR Questions

1. 13

   Why do you want to work in pharmacovigilance, especially in a healthcare or pharma setting?

   Show genuine interest in patient safety and drug safety surveillance. Connect your academic background in pharmacy, life sciences, or nursing to the role and mention that you value detail-oriented work with a direct impact on public health.

2. 14

   Describe a time when you had to pay close attention to detail under time pressure.

   Use a specific example from academics, internships, or projects. Highlight how you prioritized accuracy, cross-checked your work, and still met the deadline.

3. 15

   How would you handle a situation where you disagree with a senior reviewer about the causality assessment of a case?

   Emphasize respectful communication, presenting your reasoning with evidence from the case and reference documents, and being open to learning. The goal is patient safety and correct reporting, not winning an argument.

4. 16

   Where do you see yourself in three to five years in pharmacovigilance?

   Show a realistic growth path, such as moving from case processing to aggregate reporting, signal detection, or quality and compliance. Mention a willingness to learn new databases, regulations, and therapeutic areas.