Senior Executive - Pharmacovigilance

English
₹15000/MONTH
3 Year
Bachelor's (Preferred)
Work From Office
Apply now
Date Posted

11-Jul-2026

Location

Maharashtra (MH), 1

Job Type

Full Time

Company

Huntsman

Description

Job Title: Pharmacovigilance Executive / Specialist

Department: Pharmacovigilance
Business Unit: Critical Care
Location: Kurla, Mumbai, Maharashtra
Job Type: Full-time
Travel: No
Reporting To: Pharmacovigilance Manager


Educational Qualification:

  • Bachelor's / Master's Degree in Pharmacy


Experience Required:

  • Overall: 2–3 years of experience in Pharmacovigilance

  • Mandatory: Minimum 1 year of hands-on experience in:

    • ICSR (Individual Case Safety Report) processing

    • Literature screening

    • Authoring aggregate safety reports (e.g., PADERs, PBRERs)


Key Roles & Responsibilities:

Case Management:

  • Manage end-to-end ICSR processing including:

    • Case receipt and follow-up

    • Downloading from regulatory websites

    • Data entry, peer review, and timely submission to regulatory authorities

  • Perform mailbox management and ICSR reconciliation

  • Ensure accurate and timely case submissions to authority databases

Literature and Safety Monitoring:

  • Conduct literature screening for company products

  • Maintain and update safety logs and files

  • Draft and manage aggregate safety reports like PADERs and PSURs

Compliance & Reporting:

  • Share compliance data with QPPV

  • Provide monthly reports and safety metrics

  • Support internal and external audits/inspections

  • Coordinate with cross-functional teams for Pharmacovigilance-related data and documentation

Product Support:

  • Assist in managing product complaints and their reconciliation

  • Respond to regulatory queries regarding product safety and the PV system


Core Competencies:

  • Expertise in literature screening and aggregate report writing (PADERs, PBRERs)

  • Strong written and verbal communication skills

  • Excellent interpersonal skills for cross-functional collaboration

  • Ability to manage multiple tasks and meet strict deadlines

  • Self-motivated and collaborative team player


Technical Skills:

  • Proficient in Microsoft Word, Excel, and PowerPoint

  • Familiarity with Pharmacovigilance safety databases and reporting systems


Let me know if you'd like a condensed version for job boards or formatted for a resume attachment!

4o

 



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