Job highlights

- Perform data entry for all subject information into EDC databases as required
- Vacancy: 1 . Qualification: B Pharm M Pharm
- Perform peer review,quality review of cases as and when required
- Perform peer review,quality review of all EDC data entered as required
- Experience: 2-3 years

Senior Executive Pharmacovigilance 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 responsible and non-serious 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

Disclaimer :This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Executive Pharmacovigilance (Ahmedabad)
🏢 Pharmazone
📍 Ahmedabad