Agios is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases.
We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform.
Agios is leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and has demonstrated a strong commitment to these patient communities.
We continue to foster a productive research engine that yields new insights and potential therapeutic approaches.
We’re a company that cares about our work, each other, and the people who are counting on us the most.
We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results.
We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.
The Director, Medical Safety and Risk Management (MSRM) Operations/Case Management is accountable for the successful strategy, oversight, and execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports.
This position ensures individual reports from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials [pre-& post approval], medical information, call centers, commercial affiliates, partner companies, health authorities, post marketing commitment studies, etc.) are collected, managed and reported according to Agios’s global standard operating procedures (SOPs) and global adverse event regulations and guidelines.
This position oversees case processing activities, staffing, processes, procedures, and interdepartmental projects involving safety data captured in the global safety database.
This position collaborates within MSRM and with other company functional areas and cross-functional teams, and interacts with contract research organizations (CROs), vendors, partners, and study teams on all aspects of safety data collection and reporting.
Key Responsibilities
- Organize, direct and manage technical and human resources to efficiently support the capture and management of individual safety reports in accordance with global safety regulations in a scalable approach
- Develop, maintain, ensure training, and enforce written procedures related to the collection requirements, processing and reporting of events from clinical trials and marketed sources to ensure proactive surveillance of Agios products
- Contribute to signaling and aggregate reporting activities through ensuring quality and accuracy of individual cases through collaboration with Safety Sciences
- Manage direct report performance against goals; supporting and consulting as necessary
- Collaborate internally and with vendors to establish and monitor key performance indicators (KPIs) that are relevant and in alignment with regulations/industry standards
- Provide input to partner safety data exchange agreements and support the relationship as a primary point of contact
- Provide subject matter expertise and collaborate with MSRM Standards, Compliance and Training colleagues and vendors to ensure compliance with regulations for case quality and timely submissions
- Support MSRM and cross-functional compliance activities through the compilation and delivery of compliance metrics at required intervals/frequencies
- Serve as functional owner of SOPs, Work Instructions and Job Aids related to functional area
- Represent the functional area in internal committees and with external parties (e.g.
partners, regulatory agencies)
- Serve as a point of escalation for issue resolution
- Drive timely decisions and appropriately shift functional timelines, resources and priorities
- Collaborate with relevant departments within Agios to determine budget and resources within area of responsibility
Requirements:
- Health care professional (e.g.
RN, pharmacist, or other life sciences experience) with a minimum of 5 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology or regulatory science is a plus
- Knowledge of current industry standards and benchmarks
- Able to oversee and manage direct reports and vendors
- Extensive knowledge and experience with MedDRA and drug coding dictionaries
- Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
- Strong computer skills (MS Office)
- Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products
- Strong planning, process mapping, and organization skills
- Consistently and effectively balance decisions with imperatives for ethics and efficacy
- Strong orientation to teamwork
- Strong negotiation skills to effectively drive discussions and decisions toward desired end-results
- Excellent written/verbal communication and interpersonal skills