Demo

Safety Sciences Manager

VirtualVocations
Cranston, RI Full Time
POSTED ON 3/28/2025
AVAILABLE BEFORE 4/27/2025

A company is looking for a Sr. Manager / Associate Director of Safety Sciences.Key Responsibilities : Support signal management and safety surveillance activities using clinical trial and post-marketing dataLead author and / or contribute to the preparation of aggregate safety reports, including Development Safety Update Reports (DSURs)Prepare and review safety-related sections for clinical, regulatory, and scientific documentsRequired Qualifications : Bachelor's degree in a scientific or health-related field (advanced degree preferred, e.g., MSc, PharmD, or PhD)At least 5 years of experience in pharmacovigilance, with a minimum of 2 years in safety sciences and signal / risk managementExperience in authoring aggregate safety reports and supporting development of Investigator Brochures and related documentsStrong understanding of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines)Knowledge of clinical drug development processes, including safety governance and risk management activities

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