Manoj Kumar
Pharmacovigilance Expert| PV Client & Vendor management |Regulatory compliance| Audit & Inspection |SDEA| PV Trainer |Aggregate Report| RMP| Signal management |DSUR |ICSR| CAPA| Team handling| Subject matter expert
- Role
- Global Pharmacovigilance Manager at Biocon
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Manoj Kumar
Pharmacovigilance professional with 16 years of experience across pharmaceutical and…
Experience
Global Pharmacovigilance Manager
Sep 2024 — Present · Bengaluru, IN
Led global end-to-end pharmacovigilance (PV) operations, including-Aggregate Safety Reports (PBRERs, PSURs), DSURs, and Risk Management Plans (RMPs)-Signal detection and management, ICSR processing, safety variation handling, and risk minimization measures-Oversight of Pharmacovigilance System Master File (PSMF) and Safety Data Exchange Agreements (SDEAs)-Responded to Health Authority queries and supported Audits and Inspections, including CAPA management-Acting as Deputy QPPV, PV subject matter expert, and PV trainer-Developed, reviewed, and implemented PV Standard Operating Procedures (SOPs)-Collaborated with internal and external PV stakeholders to ensure compliance and efficiency-Managed PV service providers and vendors, including performance oversight and invoice/payments tracking-Mentored and managed team members, service providers, and associates, ensuring alignment with global PV standards and project goals-Functioned as a global PV lead, ensuring regulatory compliance, quality, and timely delivery of pharmacovigilance deliverables
Education
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor’s Degree
2002 — 2006
Sikkim Manipal University - Distance Education
Master of Business Administration (MBA in Healthcare managment)
2010 — 2012
Tamil Nadu Doctor M.G.R. Medical University, Chennai Tamilnadu
Master of Pharmacy in Pharmacology (M. Pharmacy)
2007 — 2009
The Tamil Nadu Dr. M.G.R. Medical University
Master of Pharmacy (M. Pharmacy) specialization in Pharmacology
2007 — 2009
Mahatma Gandhi Chitrakoot Gramodaya Vishwavidyalaya
Diploma In Pharmacy
1999 — 2001
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