Drug Safety Program Manager

1w1 week ago

Alkermes

Waltham, US · Full-time · $145,000 – $158,000

About this role

The Drug Safety Program Manager provides end-to-end safety leadership across clinical studies and marketed products. This role ensures compliance with ICH guidelines, regulatory requirements, and Alkermes SOPs throughout study lifecycles. Primary accountability spans from startup through closeout.

Serve as PV Safety Program Lead for assigned studies, developing and maintaining Safety Management Plans. Review protocols and amendments for safety accuracy, while ensuring all required forms like SAE reports and narrative templates are aligned. Handle daily case processing, including AE evaluation, coding, and timely reporting.

Act as PV representative on clinical project teams, integrating safety into study conduct and risk management. Provide oversight to CROs and vendors, monitoring performance, staffing, and issue resolution. Liaise with stakeholders including Clinical Operations, Regulatory Affairs, and Quality Assurance.

Oversee SAE reconciliation, SUSAR submissions, and unblinding activities in line with global regulations. Configure studies in the global safety database and review eCRF forms for alignment. Contribute to ongoing safety surveillance and preparation of IND reports and PSURs.

Requirements

Knowledge of ICH guidelines, FDA, EMA, and global pharmacovigilance regulatory requirements
Experience in adverse event case processing, including medical review, coding, and reporting
Ability to apply clinical judgment to synthesize complex clinical information into safety reports
Familiarity with SAE reconciliation, SUSAR processing, and unblinding procedures
Proficiency in safety database configuration and eCRF alignment for data quality
Skills in vendor and CRO oversight, including performance monitoring and selection
Understanding of safety surveillance for events of special interest and aggregate reviews

Responsibilities

Serve as the PV Safety Program Lead for assigned clinical studies, with end-to-end accountability for safety oversight from study startup through closeout
Ensure study-specific Safety Management Plans (SMPs) are developed, approved, implemented, and maintained in accordance with ICH guidelines and regulatory requirements
Review protocols, protocol amendments, and update requests for safety accuracy, completeness, and regulatory compliance
Responsible for the receipt, evaluation, review, coding, follow-up, and reporting of adverse event information for marketed and investigational products
Ensure SUSAR identification and submission compliance with global regulatory requirements and internal procedures
Provide day-to-day PV oversight of CROs and vendors to ensure timelines are met and issues are resolved
Ensure appropriate study configuration in the global safety database, including parameters, workflows, and reporting rules
Act as safety liaison between external reporting sources and internal stakeholders like Clinical Operations and Regulatory Affairs