Manager, Safety Scientist, Medical Safety & Risk Management
$68K-$125K (Glassdoor est.)
Manager, Safety Scientist, Medical Safety & Risk Management
Location


Agios Pharmaceuticals HQ

Job Code

1141

# of openings

1

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Manager, Safety Scientist, Medical Safety & Risk Management

Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.

Agios Pharmaceuticals is searching for a dynamic Manager, Safety Scientist to join our growing Medical Safety & Risk Management team. The Manager, 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.

Key Responsibilities

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 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
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
Minimum Requirements
Bachelor’s degree required; Health Care Professional or relevant Life Sciences
Minimum of 5 years of experience in health care or life sciences industry
Minimum of 3 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
Agios Pharmaceuticals
3.8
Agios Pharmaceuticals
