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Senior Executive – Pharmacovigilance

2-4 years
Not Disclosed
10 Sept. 22, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

ob Title: Senior Executive – Pharmacovigilance

Location: Ahmedabad, India
Department: Pharmacovigilance
Job Category: PSMFSDEAs
Vacancy: 1
Job Code: PZPV011
Experience Required: 2–4 years
Qualification Required: B.Pharm / M.Pharm


Role Overview

The Senior Executive – Pharmacovigilance will be responsible for authoring and managing aggregate safety reports, risk management plans, and signal management reports, ensuring timely and accurate reporting in compliance with regulatory requirements. The role also includes data extraction, validation, and providing support for high-priority pharmacovigilance activities.


Key Responsibilities

  • Author aggregate reports for submission to local and global health authorities, including:

    • PSURs / PBRERs

    • PADERs / Annual Reports

    • DSUR / ACO reports

  • Author Risk Management Plans (RMPs) as part of routine pharmacovigilance activities.

  • Author Signal Management Reports.

  • Perform literature searches and validate references for aggregate reports.

  • Reconcile relevant process trackers.

  • Extract and validate data from:

    • RSI (Reference Safety Information)

    • Sales data

    • Previous reports, RMPs, and signals

  • Generate Line Listings (LL) from the safety database.

  • Provide reliable support for high-priority ad-hoc pharmacovigilance activities.

  • Ensure all reports are drafted and submitted within allocated timelines.


Qualifications & Skills

  • Education: B.Pharm or M.Pharm

  • Experience: 2–4 years in pharmacovigilance

  • Strong knowledge of pharmacovigilance processes, aggregate reporting, and risk management

  • Ability to perform literature review and validate scientific data

  • Familiarity with safety databases and line listing generation

  • Excellent organizational and time management skills for meeting deadlines