Pharmacovigilance Principal Specialist

Job description

Does it excite you to work with drug safety, and do you have experience with safety strategies and safety surveillance spanning early phases of clinical development through regulatory dossier preparations for NDA/MAA? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague. Your new position: In this role, clinical safety will be shared with an experienced colleague, and the position will carry clinical safety responsibility for an early development phase project in inflammatory diseases. The role contributes to safety strategy, proactive surveillance, and cross-functional decision-making across the clinical program. The position offers broad exposure from early clinical phases through key regulatory interactions and submission activities. We offer exciting responsibilities: - Represent Patient Safety in cross-functional project teams - Represent Patient Safety in meetings with regulatory authorities - Develop the safety surveillance strategy for assigned project/clinical trials - Execute signal detection activities to support evaluation and decisions by the internal Safety Committee - Perform safety analyses and a...