Pharmacovigilance Manager, Case Processing
About The Position
The Pharmacovigilance (PV) Manager, Case Processing supervises PV staff and oversees pharmacovigilance activities, processes, and procedures, including case processing and assessment. The manager oversees adverse event intake and case processing to ensure activities comply with internal guidelines, standard operating procedures, and global safety regulations. The role collaborates with other PV managers to coordinate, develop, and maintain ProPharma’s pharmacovigilance services, and serves as a client contact for case management communications. It also contributes to process and workflow improvements and maintains a strong commitment to quality and customer service.
Requirements
- Bachelor’s degree in life sciences, or an equivalent combination of relevant education and work experience.
- At least five years of related work experience.
- At least one year of leadership experience.
- Strong verbal, written, and interpersonal communication skills with clients and internal and external staff.
- Excellent project management, problem-solving, organizational, and prioritization skills, with strong attention to detail.
- Advanced knowledge of pharmacovigilance.
- Advanced knowledge of PV systems, such as Oracle Argus Safety, ARISg, or other safety databases.
- Ability to work independently and collaboratively in a multidisciplinary team.
- Self-motivation to maintain efficiency and productivity and manage multiple projects and clients.
Nice To Haves
- An advanced degree, RN, RPh, PharmD, or equivalent.
- At least one year of people management experience.
Responsibilities
- Provide oversight and direction as a PV subject matter expert, enhancing client service internally and externally.
- Supervise workloads, provide ongoing performance feedback, and conduct annual reviews.
- Lead, coach, mentor, and motivate staff to support optimal performance.
- Make decisions and recommendations consistent with company policies and guidelines.
- Handle staffing responsibilities, including hiring, scheduling, and training.
- Foster teamwork, resolve conflicts, and communicate departmental needs to management.
- Review cases for training feedback and ensure compliance with regulatory requirements.
- Maintain and update work instructions, training materials, and templates.
- Identify and address staff training needs to ensure competency for assigned duties.
- Contribute to the development and continuous improvement of processes, SOPs, and workflows.
- Support client implementation through meetings, guideline creation, and process explanation.
- Perform billable work to meet target utilization set by the line manager; activities may include case processing, case quality control, inbox support, or other case-processing work.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
