Global Safety Lead

Merck•Billerica, MA

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
Lead benefit-risk evaluation, pharmacovigilance oversight, and safety signal management.
Ensure emerging safety profiles are rigorously monitored, clearly communicated, and strategically managed in alignment with regulatory requirements and internal governance standards.
Set the medical safety strategic direction for assigned products, providing clear and visible scientific leadership across Research and Development cross-functions.
Oversee proactive safety surveillance, signal detection and evaluation, periodic safety reporting, and risk management activities throughout the product lifecycle.
Ensure that safety signals are identified promptly and escalated appropriately within the organization.
Deliver high-quality medical safety contributions 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.
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.
Collaborate with external advisors, opinion leaders, and partner company colleagues.
Provide safety expertise for due diligence activities.
Support audit and inspection readiness.
Contribute to the coaching and development of colleagues within the therapy area team.