Safety Sciences Manager - Topeka Kansas

Company: VirtualVocations
Location: Topeka, Kansas
Posted On: 01/18/2025

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 data
Lead 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 documents


Required 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 management
Experience in authoring aggregate safety reports and supporting development of Investigator Brochures and related documents
Strong understanding of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines)
Knowledge of clinical drug development processes, including safety governance and risk management activities More...

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