Scientist Jobs in Cham

Senior PV Scientist (m/f/d)

Location: Baar, Zurich
Duration: 01.06.2026 - 31.05.2027

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 Safety Officers, Safety Physicians, and cross-functional teams on investigational and marketed products.
• Support clinical trial pharmacovigilance activities, including protocol reviews, informed consent form (ICF) reviews, safety committee management, data analysis, ad hoc safety requests, and ongoing signal detection.
• Serve as a Subject Matter Expert (SME) for global safety regulations, guidelines, data outputs, analyses, and product-specific safety information.
• Ensure clinical trial products and marketed products remain in good standing with global health authorities to support trial completion and maintenance of marketing authorisations.

Requirements

• Bachelor's degree in biological or natural sciences or a healthcare-related discipline; advanced degree (PhD, MPH, NP, PharmD, or equivalent) required depending on experience.
• Minimum of 7 years' experience in Pharmacovigilance, including proven expertise in safety signal management and aggregate safety reporting.
• Strong foundation in drug development and global pharmacovigilance regulations, including clinical trial and post-marketing safety requirements.
• In-depth knowledge of case processing, expedited reporting rules, and safety database concepts.
• Ability to understand, interpret, analyse, and clearly present scientific and medical data in both written and verbal formats.
• Demonstrated ability to independently lead complex projects such as signal management, aggregate report authoring, and regulatory authority responses.
• Working knowledge of common data processing and reporting tools (e.g. Microsoft Excel, PowerPoint, Word, Business Objects) and safety database systems.
• Strong clinical judgement to assess and interpret case-level safety information.
• Excellent organisational and prioritisation skills, with the ability to work independently with minimal supervision.
• Proven leadership skills with the ability to collaborate effectively across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external stakeholders.

In Switzerland, for contract roles it is mandatory for the candidate to be a Swiss citizen or a European passport holder.

SThree_Germany is acting as an Employment Business in relation to this vacancy.