Foram V.
Sr Director, Pv Medical Surveillance @Taiho Oncology, Inc.
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WORK HISTORY
Sr Director, Pv Medical Surveillance @Taiho Oncology, Inc.
Princeton, NJ, US
EDUCATION
M.S. University, Baroda Medical College
Bachelor of Medicine, Bachelor of Surgery (M.B.B.S.), Medicine
Harvard Medical School
Certification, CLINICAL RESEARCH FOUNDATIONS
Education Commission for Foreign Medical Graduates
Education Commission for Foreign Medical Graduates (ECFMG), Medicine
ABOUT FORAM V.
Physician with broad experience in drug safety and pharmacovigilance in highly regulated environment. Extensive experience working on various generic and Brand products’ Therapeutic Areas like Oncology, Dermatology, Cardiovascular, Rheumatology etc. Managed and coordinated regulatory agency inspections including FDA, MHRA and HC with successful outcomes. Experienced in reviewing and providing medical content input for ongoing promotional materials of the Dermatology, Oncology brand products as well as OTC generic products. Hands-on experience providing safety data review for label updates as well as supporting safety data evaluations and medical affairs strategies for new ANDA/IND applications. Responsible for leading multiple US shared REMS as well as EU RMPs in the development and maintenance of REMS and RMPs. Extensive experience in drafting, reviewing and approving Safety Data Exchange Agreements (SDEAs), PV SOPs and Guidance documents. Responsible for aggregate report review and approval. Maintaining close interaction with Medical Affairs on daily basis to address Adverse Event and Product Complaints as well as resolve medical inquiries.
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