Global Pharmacovigilance (PV) Scientist, Manager- Oncology

Role: Global Pharmacovigilance Manager supporting immuno-oncology products, responsible for safety signal detection, evaluation, and management across clinical development and post-marketing phases. Responsibilities include leading signal detection activities, conducting safety analyses, authoring aggregate safety reports (e.g., PBRERs, DSURs), providing safety input to clinical protocols, and supporting risk management strategies. Collaborates closely with Global Safety Officers, Clinical Development, Regulatory Affairs, and cross-functional teams to ensure product safety and compliance. Key duties also encompass regulatory support, inspection readiness, process improvement, and scientific leadership within a biotech environment focused on oncology, immunology, inflammation, and rare diseases. Qualifications: Doctorate, Master’s with 2+ years, Bachelor’s with 4+ years, or equivalent experience in pharmacovigilance/drug safety; advanced healthcare degrees preferred. Experience in signal detection, benefit-risk assessment, safety reporting, and supporting regulatory submissions within biotech, pharma, or CRO settings is required, with a preference for those experienced in biologics or oncology. Knowledge of global regulatory requirements (FDA, EMA, ICH) and safety databases (e.g., Argus) is essential. The role involves cross-functional stakeholder engagement, scientific judgment, and influencing safety strategies. Location: Remote, with no specified travel. The position emphasizes leadership, process improvement, and safety governance within a collaborative, science-driven culture.