Akash Sharma
Associate Pharmacovigilance Partnership Manager at Merck
- Role
- Associate Pharmacovigilance Partnership Manager at Merck Group
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Akash Sharma
Seasoned Pharmacovigilance (PV) professional with more than 13 years of experience with…
Experience
Associate Pharmacovigilance Partnership Manager
Aug 2021 — Present
Pharmacovigilance Agreements (PVAs): Lead preparation, negotiation, implementation, and lifecycle management of PVAs across post-marketing, clinical trial, and co-development settings.• Business Partner Evaluation (BPE): Conduct qualification and re-evaluation of partner PV systems, issue assessment reports, and drive action plans to ensure compliance with global regulations.• Oversight & Reporting: Support EU-QPPV with oversight of PVAs and PV systems, maintain central repositories, and deliver timely regulatory reports (e.g, PSMF Annexes, quarterly EU-QPPV updates).• Cross-functional Collaboration: Partner with GPS, Regulatory Affairs, Quality, Legal, Commercial, and CMO teams to align PV responsibilities, reconcile manufacturer databases, and enhance organizational awareness through training.• Compliance & Continuous Improvement: Support audits/inspections, contribute to process improvements, digitalization projects, and provide PV input for ISS, early/special access programs, and safety-related agreements.
Education
Loyola Institute Of Business Administration
Postgraduate Degree, Health/Health Care Administration/Management
Biju Patnaik University of Technology, Odisha
Bachelor in Pharmacy
2007 — 2011
Indian Institutes of Public Health (IIPHs)
Post Graduate Program in Health Economics, Health Care Financing and Policy, Public Health
Skills
- Quality Assurance
- Clinical Data Management
- Biotechnology
- Microsoft Office
- Pharmacovigilance
- Quality Control
- Gmp
- Validation
- Glp
- Clinical Research
- Regulatory Affairs
- Lifesciences
- Healthcare
- Formulation
- CRO
- Medical Writing
- Pharmaceutical Industry
- Sop
- Fda
- Powerpoint
- Microsoft Excel
- Analysis
- Gcp
- Clinical Trials
- Pharmaceutics
- Ich-Gcp
- V&V
- Regulatory Submissions
- Microsoft Word
- Software Documentation
- Regulatory Requirements
- Ctms
- Research
- 21 Cfr Part 11
- Clinical Development
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