11-Jul-2026
Maharashtra (MH), 1
Full Time
Huntsman
Department: Pharmacovigilance
Business Unit: Critical Care
Location: Kurla, Mumbai, Maharashtra
Job Type: Full-time
Travel: No
Reporting To: Pharmacovigilance Manager
Bachelor's / Master's Degree in Pharmacy
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)
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
Conduct literature screening for company products
Maintain and update safety logs and files
Draft and manage aggregate safety reports like PADERs and PSURs
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
Assist in managing product complaints and their reconciliation
Respond to regulatory queries regarding product safety and the PV system
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
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!
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