Global Program Safety Lead

vor 2 Wochen


Darmstadt, Deutschland Merck Group Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your Role**:
We are looking for a Global Program Safety Lead who will ensure the safety of assigned products or portfolios in collaboration with the Therapeutic Area Head. This role requires innovative strategic input and scientific leadership to maintain the integrity of safety medical assessments. You will set the medical safety strategic direction and escalate significant safety signals or issues as needed.

Proactive safety signal and benefit-risk management are vital, necessitating collaboration with various R&D functions. You will contribute safety expertise to the Clinical Development Plan, ensuring it addresses safety risks effectively. High-quality representation of Global Program Safety on cross-functional teams is essential for informed project decision-making.

Your responsibilities include overseeing benefit-risk analysis in key documents like periodic safety reports and risk management plans. You will also contribute to product-related documents, including clinical trial protocols and reports. Engaging with external experts and providing medical safety expertise for due diligence activities are also part of your role.

**Who You Are**:

- MD or equivalent with accredited residency
- Minimum of 10 years in the pharmaceutical/biotechnology industry, including 5-6 years in Global Patient Safety (esp. in analysis & interpretation)
- Profound experience in safety monitoring and strategy during clinical drug development (pharmaceutical, biotech, CRO)
- Mastery of global regulatory requirements for drug safety and pharmacovigilance
- Exceptional data analysis skills
- Proficiency in signal detection and evaluation as well as understanding of continuous Benefit-Risk Assessment
- Strong medical judgment in safety decision-making
- Proven matrix management and project leadership experience in cross-functional teams with strong influence skills
- Excellent communication and presentation skills in English, both written and oral

We also consider Switzerland as a possible location.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress



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