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Global Safety Lead Oncology (all genders) - Inklusiver Job 🦼 🦻 🦯

MerckDarmstadt, Hessen, DE

Vor 5 Tagen

Stellenbeschreibung

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

The Global Safety Lead Oncology will closely work with the Global Program Safety Lead (GPSL) to provide integrated medical safety strategies for assigned development programs or marketed products and will oversee the effective delivery of pharmacovigilance outputs including proactive safety surveillance, signal activities and benefit-risk management.

Key Responsibilities :

Set medical safety strategic direction and provide strong and visible safety scientific leadership
Ensure oversight of emerging safety profiles, including medical review of individual case safety reports, signal detection & evaluation, periodic safety reports, risk benefit evaluation and risk management
Contributions to Pharmacovigilance Advisory Board and other R&D governance bodies
represent GPS on cross-functional teams
represent GPS at submission teams and provide safety strategic input into submission documents
chair cross-functional safety teams
represent GPS on safety aspects for the product on monitoring committees (e.g. SMC / IDMC members)
preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, effective collaboration with colleagues from partnership companies for co-development or co-marketing
act as a subject-matter expert on medical safety in interactions / discussion / negotiations with regulatory authorities
ensure effective communication of product-related aspects in audits and regulatory authority inspections;
provide medical safety expertise for due diligence activities if required

Who you are

Education : Physician with clinical experience preferred.

Experience :

several years of medical experience in Oncology / Haematology is preferred.

Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations

Excellent knowledge of product development process and experience of cross-functional teamwork

Preferentially prior experience with NDA / BLA or equivalent regulatory submissions or reviews

Experienced in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological)

Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics

Skills : Strong decision-making, negotiation, and influencing skills; excellent verbal and written communication in English.

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!

Apply now and become a part of our diverse team!