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 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 bodiesRepresent GPS on cross-functional teams Represent GPS at submission teams and provide safety strategic input into submission documents Chair 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

Location: Billerica, MA, USA

Travel: