Drug Safety Manager/Senior Manager

Cost Management Incentives, Inc.

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Location: Jersey City, NJ Posted Date: 5/14/2013 Position Type: Full time Job Code: Drug Safety NJ Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research
Drug Safety

Description

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.  

Requirements

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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