Safety Evidence Medical Lead
Safety Evidence Medical Lead (arts) bij een toonaangevend immunologiebedrijf, 40 uur per week in Zwijnaarde, België.
Eisen
- 10+ years in pharma or biotech, including strategic leadership in clinical development, Medical Affairs, pharmacoepidemiology or patient safety
- Located in Switzerland, Belgium, or East Coast U.S.
- Scientific track record, such as peer-reviewed publications or conference presentations
- Comfortable with ambiguity
- Working knowledge of GCP and GVP
- Designed, interpreted or applied evidence from post-authorisation, observational or real-world studies
- Use generative AI and digital tools in your work, and understand their governance and limitations
- Medical degree
- Know immunology
Wensen
- Direct safety evidence experience
- Immunoglobulin experience
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Volledige omschrijving
Partnering with one of Europe’s leading immunology companies, we are looking for a physician to define how its therapies stand out on safety. As the label expands and the market crowds, the question becomes: how does the safety profile compare with current and emerging therapies, and what evidence will prove it? This role answers it. You’ll be hands-on and strategic in an evolving function, turning safety data into evidence that shapes how products are positioned for patients and prescribers.
About your role: You’ll turn safety data into evidence that shapes product strategy and decisions for patients and prescribers.
That means: identifying evidence gaps and building the safety differentiation elements of integrated evidence generation plans, with RWE/HEOR, Global Patient Safety and cross-functional partners; assessing the company’s products against current and emerging therapies to pinpoint differentiating attributes and evidence needs; designing real-world safety studies with pharmacoepidemiologists, and judging whether data sources are truly fit for purpose; interpreting safety evidence from multiple sources, including AI-supported outputs, with the medical judgment to know where those outputs fall short; turning findings into clear scientific narratives for decision-makers and publications; acting as the trusted safety evidence advisor to non-safety functions on study design, endpoints and interpretation; representing the company with key opinion leaders, treating physicians, regulators and external partners; testing and applying new digital and AI-enabled approaches to safety insight generation.
What you bring: Hold a medical degree and have 10+ years in pharma or biotech, including strategic leadership in clinical development, Medical Affairs, pharmacoepidemiology or patient safety; have designed, interpreted or applied evidence from post-authorisation, observational or real-world studies (direct safety evidence experience is a strong plus); bring a scientific track record, such as peer-reviewed publications or conference presentations; know immunology (immunoglobulin experience is a real advantage); are comfortable with ambiguity; use generative AI and digital tools in your work, and understand their governance and limitations; have working knowledge of GCP and GVP; located in Switzerland, Belgium, or East Coast U.S.
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