Global Safety Lead

EMD Serono, Inc.; Billerica (MA); On-site; USD 208,000 - 312,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

EMD Serono, Inc. in the United States seeks a GPS Global Safety Lead to steer integrated safety strategies across development programs and marketed products.

You will provide scientific leadership, oversee safety surveillance, signal detection, and risk management, and collaborate with regulatory bodies and cross-functional teams to ensure compliant safety reporting throughout the product lifecycle. The role requires a medical or pharmacy degree with 5+ years in drug

Qualifications

• MD or DO/PharmD with 5+ years in drug development or pharmacovigilance.
• Expert understanding of regulatory requirements and safety reporting.
• Experience authoring safety submissions and interacting with authorities.

Responsibilities

• Lead safety strategies across development programs and marketed products.
• Oversee proactive safety surveillance, signal detection and risk management.
• Engage with regulatory authorities and contribute to regulatory submissions and governance.

Skills

Medical degree

Pharmacovigilance experience

Regulatory submissions

Safety signal management

Data analytics

Oncology knowledge

Cross-functional leadership

Education

MD or PharmD

Tools

Regulatory submissions processes

Job description

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

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. Operating with a high degree of autonomy within a global matrix environment, you will lead benefit-risk evaluation, pharmacovigilance oversight, and safety signal management, ensuring that emerging safety profiles are rigorously monitored, clearly communicated, and strategically managed in alignment with regulatory requirements and internal governance standards.

You will set the medical safety strategic direction for assigned products, providing clear and visible scientific leadership across Research and Development cross-functions. This includes overseeing proactive safety surveillance, signal detection and evaluation, periodic safety reporting, and risk management activities throughout the product lifecycle. You will 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. In this role, you will 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. You will 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. You will 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.

Who You Are

Minimum 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
• Experience engaging with regulatory authorities in scientific discussions related to safety strategy during clinical development or submission processes
• 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

Preferred Qualifications

• Prior experience as a physician in a relevant therapeutic area, providing direct clinical context to safety decision-making
• Experience with NDA, BLA, or equivalent regulatory submissions, or prior work at a regulatory agency reviewing submission files
• 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
• Self-motivated with a commitment to staying current on industry trends and applying emerging scientific knowledge to benefit the organization
• Ability to present complex safety topics clearly to diverse audiences

Base Pay Range for this position – $207,600 – 311,500

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here: https://careers.emdgroup.com/us/en/benefits

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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!