Associate Director, Medical Review Lead, MSRM

The Role

The Associate Director, Medical Review Lead within Agios’ Medical Risk Management organization oversees medical review for Individual Case Safety Reports (ICSRs) for investigational and marketed products. This role ensures medical accuracy, regulatory compliance, and high-quality safety data to support pharmacovigilance and risk management activities.

Key Responsibilities

• Serve as the primary MSRM point of contact for ICSR medical review, partnering with Global Safety Leads, PV Operations, and vendors to ensure high-quality, compliant safety case assessment.
• Provide medical oversight of ICSR review for investigational and marketed products, ensuring accuracy, consistency, and scientific rigor of medical assessments.
• Review and approve key medical components of ICSRs, including narratives, coding, seriousness, expectedness, and company causality, based on source documentation.
• Perform and oversee quality control (QC) of medical review activities, providing feedback and driving vendor accountability to quality and performance standards.
• Ensure timely and compliant review of ICSR to support safety surveillance, risk management activities, and development of clinical and regulatory documents.
• Contribute to operational excellence through KPI/KQI monitoring, SOP development, training, and participation in system and process improvement.
• Support inspection readiness by identifying quality issues, contributing to CAPAs, and representing MSRM for medical review and case management activities.

Qualifications

• MD/DO with a minimum of 3 years of relevant drug safety/pharmacovigilance Medical Review experience.
• Minimum 1-2 years of vendor oversight in the biotechnology / pharmaceutical industry.
• Expertise with MedDRA and WhoDD dictionary coding.
• Expertise with software-based drug safety systems (ARGUS, ARISg, or equivalent).
• Solid understanding of expedited safety reporting.
• Solid knowledge of ICH and global regulations for clinical development and post-market activities pertaining to safety data collection, processing and reporting.
• Excellent communication and interpersonal skills including the ability to interact effectively and collaboratively in cross-functional teams.
• Excellent written and spoken English.
• Strong computer skills (MS Office).
• Ability to successfully prioritize and multi-task.