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Associate Director, Global Safety Lead
4 months ago
**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 analy
