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Safety Strategy Lead (all genders)
A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The position Safety Strategy Lead is to ensure the delivery of integrated medical safety strategies for assigned development compound(s) and/or marketed product(s) including proactive safety surveillance and effective signal and benefit-risk management. The role will set the medical safety strategic direction, in the context of delivering the benefit-risk profile, and provide clear, strong and visible safety scientific leadership, in partnership with R&D cross-functions. The Safety Strategy Lead will ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation and risk management throughout the lifecycle of the product.
Who you are:
- Physician with broad clinical experience
- Several years of medical experience as a physician, preferably clinical experience in the relevant therapeutic area
- Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations/guidelines and its application for activities related to assigned product/s
- Excellent knowledge of product development process and experience of cross-functional teamwork
- Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
- First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)
- Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics
- Professional experience in a global matrix environment across regions
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com