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Global Safety Scientist
PharmiwebLausanne, CHVor 8 Tagen
StellenbeschreibungUniversity level qualification in biosciences, healthcare, or pharmacy. A PhD in a topic relevant to the position is preferred. Experience in rare disease. Proven track record in clinical trials. Strong submission, regulatory interactions and defence, and geo-expansion beyond initial License Applications (NDA / BLA). High quality written and spoken English. Team-leadership capabilities. Relationship builder and collaborator within PV functions. Preferred experience in process development, process implementation, training development and process oversight. #LI-JP6
Position : Safety Scientist
Contract : Permanent
Location : Remote (Must be based in the EU)
Key Responsibilities
- Provide safety oversight and expertise in late phase clinical trials focusing on Rare Disease.
- Lead the collection of material for PSURs and DSURs,
- Contribute to the risk evaluation and the benefit-risk assessment.
- Main author and coordinator for the production and maintenance of core and EU-RMPs, work with stakeholders to support the preparation and maintenance of local RMPs.
- Support audits and inspections for pre-inspection requests as well as during audits and inspections
- Work effectively with the GPSSL, ensure the operation of the product level multidisciplinary Benefit Risk Team (BRT), drive signal detection, analysis and validation, risk management and minimization strategies, risk communication, and safety labelling.
Qualifications
Jobalert für diese Suche erstellen
Scientist • Lausanne, CH