Medical Director, Global Drug Safety

The Director of Global Drug Safety will be responsible for providing strategic, managerial, and medical leadership in the area of drug safety and pharmacovigilance for Alkermes products, while maintaining compliance with corporate policies and regulatory requirements.

Key responsibilities include: Oversee drug safety, pharmacovigilance, and risk management activities worldwide Medical review of adverse event reports in compliance with international and domestic regulations and guidelines Supervise the preparation of aggregate reports (eg, PSURs, NDA Periodic Reports) Detect and evaluate potential safety signals Oversee risk management activities including the development of management plans, safety strategies, and ongoing risk/benefit analysis of Alkermes proprietary and partnered products Collaborate with and oversee the management of drug safety vendors Participate in vendor selection activities Contribute to clinical and regulatory documents (IND’s, protocols, clinical study reports, regulatory submission documents, investigator’s brochures, etc.) Communication of safety issues to project teams and other stakeholders within the company and/or partners Manage and guide the professional development of drug safety employees.

Minimum Education & Experience Requirements:

Candidate must have a medical (MD) degree and at least 5 years clinical and postmarketing drug safety/pharmacovigilance experience. Expertise in drug safety requirements in the US and EU is required.

Knowledge/Skills Needed:

Thorough knowledge of drug safety regulations and guidelines in the US and EU. Experience with MedDRA, safety database management, and computerized data analysis required. Other requirements include: strong management skills, including experience leading a team; strong oral and written communication skills; ability to work in a collaborative environment including outside vendors and corporate partners.

Personal Attributes Needed:

Attention to detail; team player.

Some domestic and international travel necessary.