Medical Director of Global Drug Safety - Global Pharmaceutical Company - Boston

Meet in Roxbury, MA

  • Industry: Pharmaceutical/Biotechnology - Others
  • Type: Full Time
position filled
Medical Director of Global Drug Safety – Global Biopharmaceutical Company – Boston Summary:  Our client, an established global Biopharmaceutical company, is currently seeking a Medical Director of Global Drug Safety to assist in heading up their Pharmacovigilance department. Headquartered in Boston, MA, this client provides a rewarding, hands on environment for their employees - even those at more senior management levels. This is the perfect opportunity to join a passionate, dedicated team whose mission is to change the lives of patients and families affected by rare diseases. Role Responsibilities: Lead risk management evaluation and resolution for assigned products and projects Lead safety signal management througout product life-cycle (detection, evaluation, validation, and development of risk management strategies) Collaborate with Clinical Operations and Clinical Scientist teams to evaluate all safety triggers, thresholds, and potential safety signals Evaluate aggregate safety data and write contributions to its interpretation for PSURs, DSURs, RMPs, IB, CCSI, Safety Summaries and Clinical Overviews for the CTD, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required Desired Skills MD is required 8 years relevant safety and risk management experience in the pharmaceutical industry Thorough understanding of the principles, concepts, and theories of drug-induced disease for therapeutic / product area(s) Deep knowledge of PV deliverables, standards and processes Contact: Full job description and company details are available upon application. This position is being dealt with by Meghan McCann at Meet Recruitment, call on +1 646-569-9081 or email directly at meghan@peoplewithchemistry.com to discuss further and in confidence. You can find out more about Meghan & Meet at www.peoplewithchemistry.com

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