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 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 leadershipEnsure oversight of emerging safety profiles, including medical review of individual case safety reports, signal detection & evaluation, periodic safety reports, risk benefit evaluation and risk managementContributions to Pharmacovigilance Advisory Board and other R&D governance bodiesrepresent GPS on cross-functional teamsrepresent GPS at submission teams and provide safety strategic input into submission documentschair cross-functional safety teamsrepresent 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-marketingact as a subject-matter expert on medical safety in interactions/discussion/negotiations with regulatory authoritiesensure 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 regulationsExcellent knowledge of product development process and experience of cross-functional teamworkPreferentially prior experience with NDA/BLA or equivalent regulatory submissions or reviewsExperienced 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!