Supporting ongoing safety evaluation and pharmacovigilance activities for all products, the full-time Associate Director, Pharmacovigilance Scientist will manage serious adverse event reviews, author safety documents, and implement signal management processes in a remote work environment. Key responsibilities Perform sponsor review and approval of serious adverse event (SAE) and individual case safety reports in Argus, ensuring completeness and accuracy Author safety topic reviews, aggregate safety analyses, and benefit-risk assessments to support regulatory submissions and clinical documents Collaborate with internal teams and vendors to enhance signal management processes and ensure compliance with pharmacovigilance regulations Required qualifications Advanced degree in health sciences or life sciences (e.g., PharmD, MSN/NP, MPH) preferred; Bachelor's degree with significant relevant experience may be considered Typically 8 or more years of relevant experience in pharmacovigilance, clinical safety, or drug safety science within biotechnology or pharmaceutical settings Strong knowledge of global pharmacovigilance requirements, including ICH GCP and FDA safety reporting standards Hands-on experience with safety databases, preferably Argus, including case review and medical coding Demonstrated ability to synthesize complex clinical and safety data into clear, well-supported written assessments
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