Associate Director, Pharmacovigilance Scientist

Role: Associate Director, Pharmacovigilance Scientist, responsible for leading safety surveillance activities and ensuring compliance across the product lifecycle, from early clinical trials to post-marketing. Key duties include signal detection, benefit-risk assessment, authoring safety reports (DSURs, PBRERs), and supporting regulatory document preparation. The role involves partnering with cross-functional teams to optimize safety processes, contribute to safety governance, and maintain compliance with global regulations (FDA, ICH, EU PV). Qualifications: 8+ years in drug safety/pharmacovigilance within biotech/pharma, with at least 3 years in PV sciences; Bachelor’s in a scientific or healthcare field, advanced degrees preferred. Expertise in oncology safety data, signal detection, safety reporting, and regulatory submissions is essential. High-value specifics include focus on cancer therapeutics, safety monitoring for clinical and post-market phases, and global regulatory compliance. The position involves collaboration with drug safety teams and external partners, with an emphasis on advancing safety strategies and process improvements.