Manager/Sr. Manager, Global Safety Scientist

About the position 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. Responsibilities • 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 • 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 • 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 • Review the worldwide medical/scientific literature to identify information applicable for inclusion in aggregate reports and for potential signals • Manage external vendors for specific projects • Participate in label updates Requirements • 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 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 characterization, root causes analysis, and prioritization of potential safety risks and the definition of appropriate mitigation actions Nice-to-haves • PharmD degree • Experience in proactive pharmacovigilance processes (signal management, RMP) • Experience using a safety database • Advanced Microsoft Excel and Word skills Benefits • 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, well-being, 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. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website. • Competitive and equitable performance-based compensation. This includes 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. 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. Apply tot his job Apply To this Job