Associate Director, Global Safety Scientist, Medical Safety & Risk Management

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic and seasoned Global Safety Scientist to join our Medical Safety & Risk Management team. The Global Safety Scientist will work independently at an Associate Director level and will work closely with the Head of Global Safety Sciences and the Global Safety Leads. The Global Safety Scientist will 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 in addition to mentoring less experienced team members and having some oversight of aggregate reports. This position will support products in development and in the post-approval setting. 

What you will do:

Aggregate Reports

• Oversee aspects of aggregate reports from other team members
• 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 inquires 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

• Coordinate 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

• Mentor less experienced team members
• Manage external vendors for specific projects
• Participate in label updates

What you bring:

• Bachelor’s degree required; Health Care Professional or relevant Life Sciences 
• Minimum of 6 years of experience in health care or life sciences industry
• Minimum of 5 years of experience in pharmacovigilance
• 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 interpretation of study information from a safety perspective
• Ability to analyze data from a wide range of sources
• Intermediate analytical thinking: diagnoses complex situations, gathers and reviews relevant information from multiple sources, and exercises sound judgment in recommending solutions
• Ability to contribute to the characterization, root causes analysis, and prioritization of potential safety risks and the definition of appropriate mitigation actions

Preferred Qualifications

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

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities. 
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best. 
• Premium benefits package. We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety.  We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.