Sr. Manager,Safety Operations / Case Management, Medical Safety and Risk Management

Role Summary

Sr. Manager, Safety Operations / Case Management in Medical Safety and Risk Management will oversee the execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA. This position ensures individual reports from all sources are collected, managed and reported according to global SOPs and adverse event regulations and guidelines. It collaborates within MSRM and with other functional areas, and interacts with CROs, vendors, partners, and study teams on all aspects of safety data collection and reporting.

Responsibilities

• Contribute to the authoring, development, and ongoing maintenance of REMS materials
• Participate cross-functionally in the internal review of REMS assessment reports
• Conduct and monitor reconciliation activities related to the reporting of REMS safety events to Agios
• Track and ensure follow-up of specified safety events in accordance with REMS enhanced pharmacovigilance requirements
• Organize, direct and manage technical and human resources to efficiently support the capture and management of REMS safety data in accordance with FDA safety regulations and ICSRs in accordance with global regulations and standards
• Contribute to signaling and aggregate reporting activities of REMS and other safety data through ensuring quality and accuracy of individual cases through collaboration with Global Safety Sciences
• Ensure development and delivery of REMS-related training materials for case management vendor and safety operations team
• Support internal audits and external regulatory inspections related to REMS activities
• Contribute to safety database upgrades and configuration changes; perform user acceptance testing
• Collaborate internally and with vendors to establish and monitor key performance indicators (KPIs) that are relevant and in alignment with regulations/industry standards
• Provide subject matter expertise and collaborate with MSRM Standards, Compliance and Training colleagues, Pharmacovigilance Quality Assurance colleagues and vendors to ensure compliance with world-wide 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
• 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

Qualifications

• Required: BS/BA with health care professional (e.g. RN, pharmacist) or other life sciences experience
• Required: Minimum of 3-5 years of relevant drug safety/pharmacovigilance experience
• Required: Strong knowledge of FDA REMS requirements
• Required: Knowledge of current industry standards and benchmarks
• Required: Able to oversee and manage vendors
• Required: Extensive experience with MedDRA and WHO-DD coding dictionaries
• Required: Experience with software-based drug safety systems (e.g., ARGUS, ARISg)
• Required: Excellent computer skills (MS Office)
• Required: Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products
• Required: Strong planning, process mapping, and organization skills
• Required: Strong orientation to teamwork
• Required: Strong negotiation skills to effectively drive discussions and decisions to achieve desired end-results
• Required: Excellent written/verbal communication and interpersonal skills
• Preferred: Audit and/or inspection experience in REMS and/or pharmacovigilance

Education

• BS/BA in a health care or life sciences field (e.g., nursing, pharmacy) or equivalent professional experience