Vivek Samal, M.B., B.S., M.D.

Vivek Samal, M.B., B.S., M.D., Executive Medical Director, Vaccine Safety. Vivek brings over twenty years of pharmaceutical and healthcare experience in positions of Pharmacovigilance, Medical Affairs, and New Product Development at Merck and GSK. Vivek has contributed to safety evaluation and risk management for investigational next-generation and marketed vaccines including RSV in older adults, Meningococcal A, B, C, W, and Y in adolescents and children, diphtheria and tetanus toxoids and acellular pertussis vaccines, and vaccines for the prevention of Meningococcal B, Pneumococcus (24-valent, conjugated-10 and polysaccharide-23 serotypes), HPV (Bivalent and Quadrivalent), Herpes Zoster, seasonal Influenza, and Rotavirus (pentavalent). He has extensive biologics experience setting direction and priorities for vaccine safety, focusing on preclinical toxicology, shelf-life determination, GMP materials, Pre-IND and IND documents, CTAs, safety strategy for statistical analysis plans, and NDA/BLA/MAA submissions. Most recently, he was Global Safety Lead for FibroGen Inc, where he was hired to establish a standalone global safety organization. Vivek holds a Bachelor of Medicine and Bachelor of Surgery degree from India, and he is a Certified Clinical Pharmacologist with a Masters of Clinical Pharmacology and Toxicology.

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