Global Safety Officer

Sr. Medical Director/Medical Director, Global Safety Officer

Location: Greater Boston Area
This is a hybrid role requiring 60% in-office presence (3 days/week); not eligible for fully remote work.

The Global Safety Officer (GSO) will provide strategic safety oversight for assigned investigational and/or marketed products within a neuroscience-focused portfolio. This role reports to the Head of Drug Safety and Pharmacovigilance (DSPV) and will serve as a visible leader in cross-functional forums, governance meetings, and strategic initiatives.

The ideal candidate will have demonstrated success as a product safety physician, leading both clinical and post-marketing safety programs. They should bring deep expertise in safety surveillance, signaling, aggregate reporting, and benefit-risk assessment, with the ability to make high-impact safety recommendations. This is not a medical reviewer role - it requires strategic thinking, enterprise-level leadership, and confidence in presenting safety findings to internal governance bodies and external stakeholders.

Key Responsibilities
• Provide medical leadership within Drug Safety and Benefit-Risk Management.
• Lead safety strategy across early and late-stage clinical trials and post-marketing programs.
• Serve as the safety lead for assigned products, collaborating with cross-functional teams.
• Advise on clinical development plans, protocol design, and safety content for IBs, ICFs, and DSMBs.
• Develop and maintain Risk Management Plans and safety minimization strategies.
• Author and oversee aggregate safety reports (DSURs, PSURs, PADERs) and regulatory safety content.
• Lead safety surveillance, signal detection, and benefit-risk assessments.
• Present safety findings and recommendations in internal safety committees and governance forums.
• Respond to safety queries from regulatory authorities, ethics committees, and internal stakeholders.
• Contribute safety expertise to publications, HEOR, epidemiology, and due diligence activities.
• Represent DSPV in regulatory audits and inspections.

Qualifications
• MD or MD/PhD required (US training not mandatory).
• Minimum of 4+ years (Medical Director) or 7+ years (Sr. Medical Director) in Drug Safety & Pharmacovigilance or relevant clinical roles.
• Experience in both clinical development and post-marketing safety preferred.
• Strong understanding of neuroscience therapeutic area is highly desirable.
•  Prior experience interacting with regulatory authorities and participating in inspections.
• Proven ability to lead safety strategy and present in high-stakes governance settings.
• Strategic thinker with excellent communication and organizational skills.
•  Ability to lead and collaborate in a matrixed, dynamic, and entrepreneurial environment.
• Familiarity with global pharmacovigilance regulations and benefit-risk frameworks.