Drug Safety Manager/Senior Manager
Cost Management Incentives, Inc.
Jersey City, NJ
Drug Safety NJ
Areas of Expertise Desired:
Our client is growing and has openings for managers and senior managers in their drug safety department. Individuals will assist with SAE processing, review safety sections of protocols, investigator brochures, and informed consents. Will write and review medical assessments of adverse event reports; assists with clinical database SAE reconciliation, ensures MedDRA coding is accurate; supports risk management plans/risk evaluation mitigation strategy development, assist in planning and executing safety signal detection programs, compiles, organizes, assembles and transcribes applicable information and data for IND applications, NDA applications, Amendments, Supplements and more. this person will also be a Safety Department representative on a clinical development project team.
Minimum of Bachelor’s degree in life/health sciences; Advanced degree (PharmD PhD) or even medical degree with minimum of 3 years (Minimum of 8 years of Senior Manager ) of pharmaceutical industry experience in drug safety, medical affairs, or clinical development. Experience managing all aspects and phases of clinical and post-marketing safety surveillance. Must possess solid understanding of regulations as they apply to drug surveillance for both IND and NDA reporting. Experience authoring PADER, PSUR, ASR, and Ad Hoc safety reports. Working knowledge of safety databases such as ARISG.
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