Senior Manager, Global Case Management
About The Position
The Senior Manager, Global Case Management provides day-to-day operational support, subject matter expertise, and oversight of global Individual Case Safety Report (ICSR) management activities. The role supports case-processing workflows managed internally and by vendors, ensuring accuracy, compliance, and high-quality deliverables. It works with Clinical, Medical Safety, Data Management, and Alliance Management partners to support the safety lifecycle and timely case-management deliverables. The Senior Manager may contribute to regulatory inspections, audits, and continuous improvement by supporting process implementation, addressing operational challenges, and helping maintain inspection readiness. The position also supports clinical-trial and postmarketing safety activities, including case-related deliverables for assigned products, system and process improvements, and the preparation and remediation of CAPAs and deviations. Domestic and international travel may be required up to 10% as applicable.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- At least 3 years of experience in pharmacovigilance, case management, or related drug safety functions.
- Experience working with global teams or large-scale PV operations.
- Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, CIOMS, and other regional health authority requirements.
- Experience working with an outsourced PV model.
- Experience supporting inspections and audit participation, including presenting, responding, and leading remediation efforts.
- Proficiency with safety databases, intake tools, and related PV systems.
- Experience supporting clinical-trial safety and postmarketing pharmacovigilance activities.
- Health science background, such as PharmD, RN, or MPH.
Nice To Haves
- A master’s degree or advanced health-related degree.
- Prior involvement in system implementations or PV technology optimization.
- Experience in a global matrixed organization.
Responsibilities
- Serve as a subject matter expert for the Case Management team, providing operational guidance, technical support, and input to leadership.
- Support appropriate staffing and daily operational coverage to meet Case Management timelines and deliverables.
- Oversee day-to-day ICSR case-management operations and maintain oversight reports monitoring quality, performance, and compliance.
- Ensure compliance with internal procedures and global regulatory requirements, reporting timelines, and obligations.
- Provide operational oversight of outsourced case processing performed by the PV vendor, ensuring accuracy, consistency, and adherence to established processes.
- Develop and review training materials to support team competency, process consistency, and audit and inspection readiness.
- Collaborate with Safety Data Management to provide business input and operational requirements for enhancements to the Global Intake Tool and Global Safety Database.
- Maintain and update Data Entry Conventions, ICSR job aids, and related process documents.
- Collaborate with Clinical Study Teams and Medical Safety on case-related activities for assigned products, including SAE reconciliation, protocol reviews, Safety Management Plans, and REMS activities.
- Provide data for operational decision-making on case-management and ICSR-related issues, escalating matters as appropriate.
- Support continuous improvement initiatives to enhance efficiency, quality, and regulatory compliance.
- Review Pharmacovigilance Agreements and Safety Management Plans to ensure Case Management requirements are clearly captured and executed.
- Support regulatory authority inspections and internal or third-party audits, including serving as an interviewee and providing timely documentation and responses.
- Support preparation, tracking, and completion of CAPAs and process deviations, ensuring effective and timely remediation.
- Identify and proactively escalate operational issues or risks to enable timely mitigation.
Benefits
- Comprehensive medical insurance
- Dental insurance
- Vision insurance
- Prescription drug coverage
- Company-provided basic life insurance
- Accidental death and dismemberment insurance
- Short-term disability insurance
- Long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- 401(k) match
- Flexible time off
- Paid holidays
- Paid leave programs
- Incentive opportunity
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What This Job Offers
Job Type
Full-time
Career Level
Senior
