Pharmacovigilance Interview Questions & Answers for Freshers (2026 Master Vault)

### Q1: What is Pharmacovigilance (PV) according to the WHO? **Model Answer:** According to the World Health Organization (WHO), Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems. **Follow-up context for recruiters:** Mention that PV spans the entire medicinal lifecycle - from pre-marketing clinical trials (Phase 1–3) to post-marketing surveillance (Phase 4), ensuring patient safety and regulatory compliance across global markets (US FDA, EMA, CDSCO). ### Q2: What is the exact difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR)? **Model Answer:** - **Adverse Event (AE):** Any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. Example: A clinical trial patient takes a test drug and gets into a motor vehicle accident 2 hours later. It is an AE because of temporal association, even if not caused by the drug. - **Adverse Drug Reaction (ADR):** A response to a medicinal product which is noxious and unintended, where a causal relationship between the medicinal product and the adverse event is at least a reasonable possibility. All ADRs are AEs, but not all AEs are ADRs.

### Q3: What are the four minimum criteria required for an Individual Case Safety Report (ICSR) to be legally valid? **Model Answer:** Under ICH E2D, FDA 21 CFR 314.80, and EMA GVP Module VI, a case report must possess four core elements to be considered a valid ICSR: 1. **An Identifiable Patient**: Identified by initials, age, date of birth, gender, or patient identification number. (Full name is never required due to HIPAA/GDPR data privacy rules). 2. **An Identifiable Reporter**: Healthcare professional, consumer, or lawyer identified by name, initials, address, or qualification. 3. **At least One Suspect Medicinal Product**: The drug, vaccine, or biologic suspected of causing the reaction. 4. **At least One Adverse Event / Reaction**: The sign, symptom, disease, or abnormal lab finding experienced by the patient. ### Q4: What is 'Day 0' in Pharmacovigilance? **Model Answer:** Day 0 is the calendar day on which any employee or contracted representative of the marketing authorization holder (MAH) or pharmaceutical company first becomes aware of a case report that satisfies the 4 minimum validity criteria. The regulatory clock (e.g., 15-day expedited submission) begins on Day 0, regardless of whether the day falls on a weekend or public holiday.

### Q5: How do you differentiate between 'Seriousness' and 'Severity'? **Model Answer:** This is one of the most frequently failed questions in fresher interviews: - **Seriousness** is an official regulatory definition based on patient outcome. It determines the legal reporting clock (e.g., 15-day vs periodic). - **Severity** describes the medical intensity of the event (mild, moderate, severe) using scales like CTCAE. A severe headache is high in severity but non-serious. A transient anaphylactic shock that requires immediate epinephrine and ICU admission is life-threatening, making it serious. ### Q6: What are the 6 official Seriousness Criteria under ICH E2A? **Model Answer:** An event is classified as serious if it results in any of the following: 1. **Death**: The event directly caused or contributed to the patient's fatality. 2. **Life-Threatening**: The patient was at immediate risk of death at the time of the event. 3. **Inpatient Hospitalization or Prolongation of Existing Hospitalization**: Required overnight hospital admission. 4. **Persistent or Significant Disability / Incapacity**: Substantial disruption of a person's ability to conduct normal life functions. 5. **Congenital Anomaly / Birth Defect**: Structural or functional abnormality in offspring born to a parent exposed to the drug. 6. **Other Medically Significant Event**: Events that may not be immediately life-threatening or result in death, but jeopardize the patient or require medical/surgical intervention to prevent one of the other outcomes above (e.g., blood dyscrasias, convulsions).

### Q7: What is Causality Assessment and which methods are used? **Model Answer:** Causality assessment is the evaluation of the likelihood that a medicine was the causative agent of an observed adverse event. Standard methods include: - **WHO-UMC Causality Scale**: Categories: Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable. - **Naranjo Algorithm**: A 10-question scoring questionnaire yielding a probability score from Definite (≥9) to Doubtful (≤0). ### Q8: What is 'Expectedness' and what document is used to determine it? **Model Answer:** Expectedness determines whether the nature, severity, or frequency of the adverse event has already been documented in the authorized Reference Safety Information (RSI): - For **approved, marketed drugs**: Determined using the **Summary of Product Characteristics (SmPC)** or US Package Insert (USPI). - For **investigational drugs in clinical trials**: Determined using the **Investigator's Brochure (IB)**. If an event is not listed in the RSI, it is classified as **Unexpected**. A Serious Unexpected Suspected Adverse Reaction is designated as a **SUSAR**.

### Q9: Explain the 5-level hierarchy of the MedDRA dictionary. **Model Answer:** The Medical Dictionary for Regulatory Activities (MedDRA) is organized into 5 hierarchical levels: 1. **SOC (System Organ Class)**: Highest level (27 SOCs), grouping by etiology, site, or purpose (e.g., Cardiac disorders). 2. **HLGT (High Level Group Term)**: Subordinate to SOC (e.g., Coronary artery disorders). 3. **HLT (High Level Term)**: Subordinate to HLGT (e.g., Ischaemic coronary artery disorders). 4. **PT (Preferred Term)**: Single medical concept; the standard level used for reporting and signal detection (e.g., Myocardial infarction). 5. **LLT (Low Level Term)**: Lowest level (~85,000+ terms), mapping verbatim text entered by reporters (e.g., Heart attack). **Rule of Thumb:** Verbatim reports code directly to an LLT, which automatically maps to its unique parent PT.

### Scenario A: Incomplete Report Triage *Question:* "A consumer calls stating: 'My friend took your Paracetamol 500mg tablet and developed a severe rash.' Does this qualify as a valid ICSR?" *Answer:* **No, this is currently an invalid case.** - Suspect drug: Paracetamol (Present) - Adverse event: Severe rash (Present) - Reporter: Consumer / Friend (Present) - Patient: 'My friend' (Non-identifiable: no age, gender, initials, or identifiable characteristics). *Next Step:* The safety associate must log this as an inquiry/triage hold and attempt a follow-up call to capture the patient's age, gender, or initials to validate the ICSR. ### Scenario B: De-challenge and Re-challenge *Question:* "What is positive de-challenge and positive re-challenge?" *Answer:* - **Positive De-challenge**: The suspect drug is withdrawn or dose reduced, and the adverse reaction abates or resolves. Strongly supports causality. - **Positive Re-challenge**: The drug is re-introduced after de-challenge, and the exact same adverse reaction recurs. This provides the highest evidence of a causal relationship (Certain under WHO-UMC).

### Q10: "Tell me about yourself" (For B.Pharm / Pharm.D Freshers) **Model Script:** *"Good morning. I graduated with a B.Pharm degree from [College Name], where I developed a strong foundation in pharmacology, clinical therapeutics, and toxicology. During my final year, I realized my passion lay in corporate clinical data and drug safety rather than retail pharmacy or manufacturing.* *To prepare for a Drug Safety Associate role, I completed intensive hands-on simulation training on the ICSR lifecycle, MedDRA coding hierarchy, and ICH E2B(R3) guidelines. I have practiced processing 50+ simulated safety cases - verifying the 4 validity criteria, drafting chronological narratives, and evaluating causality using WHO-UMC and Naranjo scales.* *I am eager to contribute my technical knowledge, precision, and adherence to regulatory compliance to the Pharmacovigilance team at [Company Name]."*