Associate Manager pharmacovigilance operations
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Considerable drug safety knowledge and experience in pharmacovigilance/drug safety profile. 10 years of experience in Pharmacovigilance (PV) with expertise in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, device, solicited programs and literature articles) which include triage, registration, duplicate search, data entry, Medical Dictionary for Regulatory Activities (MedDRA) coding, data validation, quality review and quality checks of ICSRs. Have worked with international clients and experienced in organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting. Mentored PV scientists in various activities of case processing of all kind of products (drug and device).
Managed mentoring for the new recruits and conducting refresher trainings for the PV staff. Equipped to work different types of databases.
Project Manager & Pharmacovigilance Expert with 10+ years of experience leading end-to-end PV operations, ensuring compliance (FDA/EMA/ICH), and driving process automation.
✅ Leadership in PV Operations Managed 1200+ ICSRs/month, led teams of 27+, and optimized workflows (40% efficiency gain via automation).
✅ Compliance & Quality: Ensured 100% SLA adherence, conducted audits/CAPAs, and served as SME for regulatory submissions (FDA/EMA).
✅ Process Innovation: Automated ICSR workflows, implemented AI tools for language processing, and standardized SOPs to reduce errors.
✅ Vendor & Stakeholder Management: Improved vendor KPIs, acted as primary PV liaison for EU/US clients, and translated complex data into strategic reports.
✅ Training & Development: Trained 250+ scientists in MedDRA coding, mentored freshers, and won awards for performance excellence.
✅ Career Break (2023–Present): Pursued holistic wellness upskilling, now eager to return to PV with renewed analytical rigor.
Chitkara College of Pharmacy, Chitkara University (2012)
Sardar Bhagwan Singh PGI of Biomedical Sciences (2010) & research
Licensure & Membership
