Global Safety Lead
- Acting as a drug safety expert and providing global safety medical leadership for assigned products (investigational products after proof of concept and authorized products).
- Developing and maintaining a development safety strategy for assigned medicinal products
- Characterize, establish and re-state the benefit-risk profile of assigned products
- Strategic drug positioning in collaboration with other internal functions incl. publication of safety data
- Developing and maintaining the global safety profile for assigned product(s) incl.
- strategic, proactive risk assessment (safety risk identification and mitigation), develop and maintain risk management strategies and plans (e.g. RMP, REMS), and monitor effectiveness
- proactive safety review of aggregate safety data including signal detection/validation and evaluation
- preparing, coordinating, reviewing, and validating periodic reports such as Risk Management Plans, Periodic Benefit Risk Evaluation Report, Development Safety Update Reports and other related safety documents
- Coordinating the preparation of meetings & acting as the spokesperson through the agenda of Safety Management teams with senior management
- A scientific university degree in medicine or pharmacy, with a doctoral degree
- Clinical experience as a physician would be a plus
- Excellent Project Management skills
- Excellent in scientific interpretation & writing
- In depth understanding of pharmacovigilance regulations and standards
- Very good knowledge of English (both spoken and in writing); knowledge of German and Spanish would be a plus.
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