PSRI Hospital Pharmacovigilance Analyst Interview: Rounds, Questions and Preparation

What the job involves

Pharmacovigilance Analysts monitor and assess the safety of medicines after they reach the market. They collect adverse event reports, enter them into safety databases, code them using MedDRA, assess causality and seriousness, and help prepare periodic safety reports for regulatory authorities. In a hospital or fast-growing pharma company, the day often involves triaging case reports, following up with reporters for missing information, and ensuring compliance with timelines and SOPs.

Role and Technical Knowledge

1. 1

   What is pharmacovigilance and why is it important after a drug is approved?

   Define PV as science and activities relating to detection, assessment, understanding, and prevention of adverse effects. Explain that clinical trials have limited patients and duration, so post-marketing surveillance catches rare or long-term ADRs.

2. 2

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

   An adverse event is any untoward medical occurrence after drug use, which may not be causally related. An adverse drug reaction is a response to a drug that is noxious and unintended, with at least a reasonable possibility of causal relationship.

3. 3

   What are the criteria for classifying a case as serious?

   List the ICH criteria: death, life-threatening, hospitalization or prolongation of hospitalization, disability or incapacity, congenital anomaly or birth defect, or medically important event requiring intervention to prevent one of these outcomes.

4. 4

   What is MedDRA and why is it used in pharmacovigilance?

   MedDRA is the Medical Dictionary for Regulatory Activities, a standardized terminology for coding adverse events. It allows consistent coding and analysis across countries and companies, with a five-level hierarchy from LLT to SOC.

Practical Scenarios and Case Handling

1. 5

   A patient reports a mild rash after taking an antibiotic. How would you handle this report?

   Describe the steps: collect minimum information (patient details, drug, event, reporter), assess seriousness (likely non-serious), code the event, enter into database, and follow up if needed. Mention that even non-serious cases must be recorded and reported per timelines.

2. 6

   What is the expected reporting timeline for a serious unexpected adverse reaction in India and why?

   For serious unexpected ADRs, the timeline is 15 calendar days to CDSCO and the marketing authorization holder. Explain that quick reporting helps regulators assess signals and take action to protect public health.

3. 7

   How would you assess causality between a drug and an adverse event?

   Mention using WHO-UMC scale or Naranjo algorithm. Consider temporal relationship, known reaction profile, dechallenge and rechallenge, alternative causes, and plausibility. Conclude with a category like certain, probable, possible, unlikely, or unassessable.

4. 8

   You receive a report with missing information like patient age and onset date. What do you do?

   Explain that you would document what is available, mark the case as incomplete, and attempt follow-up with the reporter within the required timeline. If follow-up fails after reasonable attempts, document it and proceed with available data.

Regulatory and Documentation

1. 9

   What is the difference between a PSUR and a PBRER?

   PSUR is Periodic Safety Update Report, historically used for periodic reporting. PBRER is Periodic Benefit-Risk Evaluation Report, which has a stronger focus on benefit-risk assessment and is now the preferred format under ICH E2C(R2).

2. 10

   What is signal detection and how is it done?

   Signal detection is the process of looking for new or changed safety information that suggests a causal association. It can be done through manual review, statistical methods like disproportionality analysis, and review of individual case reports.

3. 11

   What does ALCOA stand for in good documentation practices?

   ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. Explain that these principles ensure data integrity in PV records and are essential for audits and inspections.

4. 12

   What are the key sections of an adverse event case report form?

   Cover patient demographics, reporter information, suspect drug details, concomitant medications, event description with dates, seriousness criteria, causality assessment, and outcome. Mention that completeness is critical for valid assessment.

Behavioural and HR Questions

1. 13

   Why do you want to work in pharmacovigilance, especially in a hospital or fast-growing company?

   Show genuine interest in patient safety and drug safety monitoring. Mention that a hospital or growing company offers hands-on exposure to real-world ADRs and close collaboration with clinicians, which helps build a strong foundation.

2. 14

   How do you handle repetitive data entry work while maintaining accuracy?

   Emphasize attention to detail, use of checklists, double-checking entries, and taking short breaks to avoid fatigue. Mention that accuracy in PV directly impacts patient safety, so you treat every case with care.

3. 15

   Tell me about a time you had to follow a strict deadline or SOP.

   Use a specific example from college projects, internships, or part-time work. Describe the situation, what you did to stay compliant, and the positive outcome. Highlight your ability to follow rules and manage time.

4. 16

   Where do you see yourself in three years in this role?

   Show ambition to grow into senior PV roles, gain expertise in signal detection or aggregate reporting, and possibly take on mentoring or training responsibilities. Keep it realistic and aligned with the company's growth.