Senior Manager/Associate Director, Global Safety Scientist, MSRM

The role

Agios Pharmaceuticals is seeking a Global Safety Scientist to join our Medical Safety & Risk Management team. The ideal candidate will care about connecting with our mission of helping rare disease communities and will be driven to support the development of innovative medicines.

Responsibilities

• Aggregate Reports
  • Coordinate the process to prepare to aggregate report generation, including kick off meeting, project planning, and source data parameters
  • 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
  • Cover, assemble, and format all aggregate report sections
  • Distribute approved aggregate reports to internal stakeholders
  • Coordinate draft responses for regulatory authority inquiries on aggregate reports
• Signal Detection
  • Perform routine signal detection activities
  • Support evaluation and characterization of safety topics
• Risk Management Plans
  • Coordinate the development, review, and approval of RMPs and oversee 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

Qualifications

• Bachelor’s degree required, Health Care Professional or relevant Life Sciences Health care professional (e.g. RN, pharmacist, or other life sciences experience) with a minimum of 4-6 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology or regulatory science is a plus
• Experience in preparation of aggregate reports
• Experience with signal detection tools and processes
• Experience in preparation of Risk Management Documents (RMPs, REMS)
• Advanced 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 interpretation of study information from a safety perspective
• Intermediate analytical thinking: diagnoses complex situations, gathers and reviews relevant information from multiple sources, and exercises sound judgment in recommending solutions
• Ability to analyze data from a wide range of sources

Preferred Qualifications

• PharmD degree
• Experience in proactive pharmacovigilance processes (signal management, RMP)
• Advanced Microsoft Excel and Word skills

What we offer

• Deliberate Development: Your professional growth as one of our top priorities
• Flexibility: We’re all about individual needs
• Premium benefits package: Well-rounded and flexible to help meet the varied personal and professional needs of every member of our team
• Competitive and equitable performance-based compensation: Base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance
• Psychological safety: We support an environment of fearlessness
• Commitment to diversity: We strive to foster a welcoming workplace where everyone can thrive
• Commitment to community: We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked