Omprakash Nandedkar

About Omprakash Nandedkar

Experienced Assistant Manager:I have 13.3 years of core pharmacovigilance (PV)/drug safety experience. Before i started my career in PV I had 6 months of clinical research experience with an investigator site (serum institute of India). Well-versed with site assessment, site initiation and interim site visits as well as coordinating responsibilities at an investigator site like handling documents, drug accountability, EC submissions, etc. During my drug safety career i have played different roles like triage,case processing in ARGUS and ARISg (E2b R2 and R3), mentoring new pharmacovigilance scientists in individual case safety report (ICSR) with different case scenarios, expedite reporting (Day 7 and Day 15 SUSAR), quality review (QR)(including legal cases), serious adverse event (SAE) reconciliation to synchronize clinical/safety data base, safety matter expert (SME), emergency patient unblinding (blind break activity), compliance monitoring and medical communication. Pharmacology experience including clinical experience in reporting post-marketing events, in-depth knowledge of US and ICH safety regulations and guidelines (E2a, E2b and E2d),EMA submissions, basic understanding of FDA, international regulations and proficiency in data entry and drug safety database. Key expertise: Actively involved in team building and motivation, team management, skilful in getting work done within timeline, excellent decision making skill with positive approach, effectively handled adhoc project within process as per regulatory requirement. A profound experience in managing training sessions, root cause analysis (RCA), corrective and preventive action (CAPA), EMA submission, service level agreement (SLA) and management.ICSR automation and Argus update,Quality improvement and Vendor Manahement,Audit and inspection readiess,Management of global PV operation documents,Training,mentoring and development- facilitate operations excellence.

Experience

1. Deputy Manager

   Viatris

   Mar 2026 — Present · Telangana, IN

Education

• Tamil Nadu Dr. M.G.R. Medical University (TNMGRMU)

  B. Pharmacy, Pharmaceutical Sciences

• Tamil Nadu Dr. M.G.R. Medical University (TNMGRMU)

  M. Pharmacy, Pharmacology

Skills

• Microsoft Word
• Microsoft Excel
• Powerpoint
• Pharmacovigilance
• Microsoft Office
• Clinical Trials
• Public Speaking
• Gcp
• Research
• English
• Medical Writing
• Outlook