Associate Director, Safety Science
W2 Contract
Salary Range: $251,700 - $272,500 per year
Location: Novato, CA - Hybrid Role
Job Summary:
The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals.
Duties and Responsibilities:
Requirements and Qualifications:
Desired Skills and Experience
Signal detection, aggregate safety reports, ICSR review, MedDRA coding, seriousness assessment, expectedness assessment, causality assessment, regulatory reporting, medical review, pre-marketing safety data, post-marketing safety data, safety surveillance, risk management plans, expedited reports, 15-day Alert Report, SUSAR, PSUR, PBRER, US PADER, Annual Safety Report, DSUR, IND Annual Report, Safety Management Team participation, cross-functional collaboration, clinical operations liaison, medical affairs liaison, biostatistics liaison, regulatory affairs liaison, CRO management, Data Monitoring Committee interface, product labeling, RMP preparation, investigator brochures, protocol safety sections, informed consent forms, statistical analysis plans, clinical study reports, NDA submissions, BLA submissions, CTD submissions, safety documentation, Data Exchange Agreements, business partner interface, Argus safety database, signal evaluation, signal issue work-ups, Product Safety Committee, BSN, RN, PharmD, MD, DO, healthcare degree, pharmaceutical safety, drug safety, pharmacovigilance
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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