Work Your Magic with us! Start your next chapter and join EMD Serono.

 

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 collaborate with the Global Program Safety Lead (GPSL) to develop 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:

Establish medical safety strategic direction and provide visible safety scientific leadership.Oversee emerging safety profiles, including medical review of individual case safety reports, signal detection and evaluation, periodic safety reports, and risk management.Contribute to the Pharmacovigilance Advisory Board and other R&D governance bodiesChair cross-functional safety teams and represent GPS on cross-functional teams represent GPS at submission teams and provide safety strategic input into submission documents represent GPS on safety aspects on monitoring committees (e.g. SMC/IDMCs)Prepare for and attend regulatory meetings, collaborating with external advisers and opinion leaders, effective collaboration with colleagues from partnership companies Serve as a subject-matter expert in medical safety during regulatory discussions.Ensure effective communication of product related aspects during audits and regulatory inspections.Provide medical safety expertise for due diligence activities as needed.

Who You Are

Minimum Requirements:

MD with a minimum of 5 years of broad industry experience, including clinical development and pharmacovigilance. Or PharmDStrong knowledge of pharmacovigilance regulations and product development processes.Experience managing safety issues related to target organ toxicities.Expertise in aggregate data analytics and related sciences (predictive modeling, epidemiology, health outcomes, biostatistics).Strong decision-making, negotiation, and influencing skills.Excellent verbal and written communication in English.

Preferred Requirements:

Clinical experience, particularly in Oncology/Hematology.Prior experience with NDA/BLA or equivalent regulatory submissions.

Location: Billerica, MA, USA

Travel: