Manager​/Sr. Manager, Global Safety Scientist

Overview

Manager/Sr. Manager, Global Safety Scientist, Medical Safety & Risk Management

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate.

Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built. To learn more, visit  and follow Agios on Linked In and X.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Safety Scientist to join our growing Medical Safety & Risk Management team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Safety Scientist will work closely with the Head of Safety Sciences and the Global Safety Leads and be responsible for leading and planning the development of aggregate safety reports, signal detection review, authoring and analyzing data for safety topic reports, and creation and update of risk management plans.

This position will support products in development and in the post-approval setting.

Aggregate Reports

• Coordinate the process to prepare to aggregate report generation, including kick off meeting, project planning, and source data parameters
• Coordinate input from all Subject Matter Experts
• Work with systems to ensure source data and standard and ad hoc safety database queries and reports are generated for aggregate reporting
• Gather, review, and analyze safety data to generate assigned sections of aggregate reports
• Review, assemble, and format all aggregate report sections
• Coordinate the review and approval of aggregate reports
• Distribute approved aggregate reports to internal stakeholders
• Coordinate draft responses for regulatory authority inquiries on aggregate reports

Signal Detection

• Perform routine signal detection activities
• Perform medical analyses to support evaluation and characterization of safety topics
• Work closely with Global Safety Leads
• Participate in the safety governance meetings, provision of data and review of analysis

Risk Management Plans

• Coordinates the development, review, and approval of RMPs and oversees the maintenance of these documents
• Collaborate and/or author new RMPs
• Manage the process internally for RMP generation/updates

Literature Surveillance

• Review the worldwide medical/scientific literature to identify information applicable for inclusion in aggregate reports and for potential signals

Other

• Manage external vendors for specific projects
• Participate in label updates

• Bachelor’s degree required, Health Care Professional or relevant Life Sciences
• Minimum of 4 years of experience in health care or life sciences industry, or equivalent
• Minimum of 3 years of experience in pharmacovigilance, or equivalent
• Experience in preparation of aggregate reports
• Knowledge of applicable safety regulations (FDA, EMA, ICH, CIOMS, GCP and other regulatory guidelines. Includes knowledge of case processing, event coding, expedited reporting rules, and safety database concepts
• Strong medical and scientific writing; conveys medical and scientific concepts clearly and effectively
• Strong Microsoft Excel, Word, and PowerPoint skills
• Advanced written and verbal communication skills
• Works effectively in a team and independently
• Strong planning and project management skills
• Applies working knowledge of pharmacovigilance processes and requirements to complex situations; working knowledge of applicable global regulatory requirements
• Applies working knowledge of medical concepts, terms, conditions, and associated pathology to identify and analyze potential safety issues
• Applies working knowledge of clinical pharmacology and toxicology to…