Pharmacovigilance Scientist

Job Summary

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