Senior PV Scientist

Senior PV Scientist (m/f/d)

Location: Baar, Zurich
Duration: -

Responsibilities

• Lead the safety signal management process for assigned products, including signal detection, tracking, documentation, evaluation, and decision-making.
• Synthesise safety data from multiple sources and author signal evaluation reports.
• Chair and lead Safety Signalling Team meetings and manage ongoing safety signal reviews.
• Oversee and manage literature reviews for identification of relevant safety information.
• Lead the preparation, review, strategy, and finalisation of aggregate safety reports, including PSURs, DSURs, line listings, Pharmacovigilance Plans, REMS, and Risk Management Plans (RMPs).
• Act as the primary point of contact for responding to safety-related questions from global regulatory authorities.
• Collaborate closely with Global...