The Vice President of Drug Safety and Pharmacovigilance will provide strategic leadership and operational oversight to ensure the safety and benefit-risk balance of Alkermes’ investigational and marketed products. This role will be responsible for shaping and advancing the company’s Drug Safety and Pharmacovigilance function while fostering strong cross-functional collaboration. Additionally, this leader will serve as a key voice in safety-related decision-making, contributing expertise to regulatory submissions, labeling strategies, and corporate governance.

Responsibilities

• Serve as a pragmatic, strategic leader with a steady, clear voice for Drug Safety and Pharmacovigilance, fostering strong collaboration and high rapport with cross-functional partners
• Provide clear and effective communication on product safety and benefit risk issues to internal and external stakeholders
• Actively participate in protocol review and publications review committees, ensuring consistency and appropriate context of safety information provided
• Oversee all facets of Drug Safety and Pharmacovigilance: Lead ongoing safety medical support for product teams, including safety reviews, adverse event signal detection and product complaint monitoring
• Ensure timely and accurate generation of aggregate safety reports and responses to regulatory authorities
• Maintain a proactive benefit-risk strategy for all investigational and marketed products
• Direct in-house and outsourced safety operations, including global case processing and submissions, safety database management, and department quality, training and compliance functions
• Oversee epidemiology activities supporting safety signal investigations
• Drive DSPV staff development, ensuring alignment with departmental and corporate objectives through strategic goal setting, budgeting, and resource planning
• Serve as Chair of Safety Committee and member of the Labeling Committee (i.e., Company Core Data Sheets and local labeling)
• Responsible for final review and sign off with respect to all DSPV-related controlled documents

Qualifications

• MD or equivalent
• Deep expertise in drug safety with 15+ years of industry experience focused in Drug Safety, Risk Management, and Pharmacovigilance
• Previous experience in the management of drug safety across all phases of drug development, from pre-IND to Phase 4, is preferred. Exposure to significant drug safety issues, such as clinical holds, is also preferred
• Strong emotional intelligence with exceptional verbal and written communication skills
• Demonstrated experience in building and managing teams, with a track record of developing employees
• Extensive knowledge of safety systems and processes for  handling, processing, analysis and global regulatory reporting of adverse event reports, including serious adverse events
• Knowledge of global safety reporting requirements from a regulatory perspective
• Ability to navigate complex clinical programs, managing significant accelerations and unforeseen challenges
• Outstanding leadership and collaboration skills in a matrix environment
• Comfortable engaging with senior executives, board members, and external stakeholders, including KOLs and regulatory agencies

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. 

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.