- Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources
- Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
- Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
- Responsible for identifying duplicate/invalid ICSRs
- Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-reliable reports
- Perform data entry for all subject information into EDC databases as required
- Perform peer review, quality review of cases as and when required
- Perform peer review, quality review of all EDC data entered as required
- Accountable for sending queries for clarity associated with incoming information if required
- Ensure accurate and consistent coding of all the events,



drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
- Ensure that case narrative comprises correct and appropriate safety information
- Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement.
- Contributes to safety and pharmacovigilance training programs.
- Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
- Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
- Training and mentoring of Pharmacovigilance Associates

Department: Pharmacovigilance

Job Category: ICSR

Vacancy: 1

Qualification: B. Pharm. M. Pharm.

Experience: 2-3 years

Job Code: PZPV012

Job Location: Ahmedabad

📌 Senior Executive – Pharmacovigilance (India)
🏢 Pharmazone
📍 India