Hiring: Global Safety Lead Company: EMD Serono, Inc. Location: Billerica, MA Job Posted Time: 2026-09-10 11:46:26 Employment Type: On-site Target Skills & Keywords : Risk Management About the job Experience: •5 years of broad industry experience in drug development, pharmacovigilance, or related discipline Required Skills: •As a GPS Global Safety Lead, you will serve as a recognized scientific authority on medical safety, shaping and driving integrated safety strategies for assigned development programs and marketed products across their full lifecycle. •Set the medical safety strategic direction for assigned products, providing clear and visible scientific leadership across Research and Development cross-functions. •Ensure that safety signals are identified promptly and escalated appropriately within the organization, and that high-quality medical safety contributions are delivered to the Global Safety Committee and other governance bodies. •Represent the Global Patient Safety function on cross-functional program teams, including Program Steering Teams where delegated, and will provide strategic safety input into regulatory submission documents such as the Integrated Summary of Safety, Clinical Summary of Safety, and Clinical Overview. •Engage directly with regulatory authorities as a subject-matter expert, lead or co-chair relevant safety committees, and collaborate with external advisors, opinion leaders, and partner company colleagues. •Also provide safety expertise for due diligence activities, support audit and inspection readiness, and contribute to the coaching and development of colleagues within the therapy area team. Qualifications: •Medical degree (MD or equivalent), or pharmacy degree, with a minimum of 5 years of broad industry experience in drug development, pharmacovigilance, or related discipline •Demonstrated expertise in pharmacovigilance regulations and guidelines, including their practical application across the product lifecycle •Proven experience authoring complex benefit-risk reports and safety submission documents, including regulatory dossier components •Hands-on experience managing safety issues related to known target organ toxicities and a solid medical understanding of at least one relevant therapeutic area •Expert knowledge of aggregate data analytics and familiarity with related disciplines such as epidemiology, predictive modelling, health outcomes research, and biostatistics •Deep experience within the assigned therapeutic area: oncology •Prior experience as a physician in a relevant therapeutic area, providing direct clinical context to safety decision-making •Demonstrated ability to chair or actively lead high-profile cross-functional meetings and governance boards •Track record of operating effectively in a global matrix environment, managing multiple stakeholders across regions and functions •Strong scientific leadership skills with the ability to influence strategy, foster accountability, and develop team members Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!