Senior Medical Director, Drug Safety & Pharmacovigilance

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The Senior Medical Director/Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight for the Alkermes Neuroscience portfolio, overseeing investigational and marketed products. Reporting to the Head of DSPV, the GSO will serve as a safety advisement leader in various company-wide forums and initiatives.

Key Responsibilities include:

• Providing medical leadership within Drug Safety Benefit-Risk Management, including safety oversight, strategic advisement on clinical development plans, safety content of clinical documents, and regulatory safety content.
• Managing safety strategies, including Risk Management Plans and aggregate safety reports (DSUR, PSUR, PADER).
• Collaborating on post-approval safety studies and contributing to publications and epidemiology projects.
• Leading product safety surveillance, signaling activities, and benefit-risk assessments.
• Engaging with cross-functional teams and leadership to communicate safety issues and strategies.

Qualifications:

• MD or MD/PhD required.
• Minimum 8 years of experience in Drug Safety & Pharmacovigilance or relevant clinical experience.

Preferred Skills:

• Experience in neuroscience, clinical development, and pharmacology.
• Strong strategic, leadership, and communication skills.
• Knowledge of US and EU regulations.

This role supports a hybrid work environment in Waltham, MA, requiring onsite presence at least 3 days a week. It is not fully remote.

About Us: Alkermes is committed to neuroscience research and developing medicines for psychiatric and neurological disorders, fostering a diverse and inclusive culture.