Atul Kolhe
Associate Medical Safety Director (Global Safety Officer) at IQVIA
- Role
- Associate Medical Safety Director (Global Safety Officer) at IQVIA
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Atul Kolhe
A pharmacovigilance physician with over 10 years of total work experience in drug safety,…
Experience
Associate Medical Safety Director (Global Safety Officer)
May 2022 — Present · Pune, IN
Provide PV expertise for assigned products-Neurology, maintains PV expertise, and understanding of international safety regulations and guidelines.• Responsible for signal detection for Phase & phase IV studies and developing Risk:Benefit strategies with the global safety group. Responsible for management of global safety lifecycle of the products in Neurology therapeutic area which included ongoing review and assessment of the safety profile of the product, benefit-risk assessment, aggregate review, risk management plans, submission documents, label updates and responding to health authority questions.• Provides and maintains PV and risk management expertise to internal and external customers, developing Risk:Benefit strategies with the global safety group.• Responsible for signal detection and analysis as well as review, preparation, and/or contribution to responses to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners. • Responsible for documenting, coordinating, reviewing and validating periodic reports, e.g-PBRER, RMP update, Periodic Safety Update Report, Health Hazard Evaluation etc.
Education
B. J. Medical College
Bachelor of Medicine, Bachelor of Surgery (M.B.B.S.), Medicine
2006 — 2011
Modern college , Pune
H.S.C., Science
2003 — 2005
Govt. Medical College, Ambajogai
Doctor of Medicine (M.D.), Pharmacology
2013 — 2016
Skills
- Clinical Trials
- Good Clinical Practice (Gcp)
- Clinical Research
- Clinical Pharmacology
- Medical Writing
- Pharmacology
- Pharmaceutical Industry
- Pharmacovigilance
- Clinical Development
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