Sr. Manager-Phamacovigilance required at Biocon
Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Post: Sr. Manager-Phamacovigilance
The incumbent should provide global drug safety and phamacovigilance surveillance for marketed and investigational products. S(he) should provide case management and maintain phamacovigilance and drug safety operations. S(he) should conduct medical assessment, determine additional information needed and independently generate drug safety. S(he) will be responsible for drug safety crisis management. S(he) will overlook the signal detection and risk management activities for designated global products. S(he) should design and implement systems for drug safety collection, processing, reporting and coding. S(he) will be involved in making strategies for pre and post marketing risk management and should keep abreast of phamacovigilance methods and trends in published literature and global regulation. The position will be in the quality department and the incumbent will report to the head of quality.
-MD-Pharmacology with 6-10 yrs of experience in phamacovigilance or M.Pharm/Ph.D with relevant work experience.
-Experience in contract research organization orpharmaceutical/ Biotechnology Company is a must.
-In-depth clinical background is needed. Should have good knowledge of EMEA, Non-EU and FDA regulation.
-Should have strong knowledge of worldwide safety regulation for marketed and investigational products.
-Should have industrial knowledge experience in drug safety and phamacovigilance and FDA and global regulations related to drug safety reporting, ICH guidelines, and GCP and the process required to comply.
Experience: 6-10 years
Education: M.Pharm, MD, Ph.D
Industry Type: Biopharmaceuticals/ Pharmaceuticals/Chemical / Biotech/Clinical Research /API
Functional Area: Phamacovigilance
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