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 role provides oversight of adverse event intake and case processing to ensure activities comply with internal guidelines, SOPs, and global safety regulations. The manager collaborates with other PV management to coordinate, develop, and maintain ProPharma’s pharmacovigilance services, acts as a client contact for case management communications, and supports process, workflow, and document improvement. The position maintains a focus on quality and customer service for internal and external stakeholders. The role also performs billable work, such as processing or quality-checking cases and assisting with the inbox, in line with utilization targets set by the line manager based on span of control. Other duties may be assigned.
Requirements
- Bachelor’s degree in life sciences, or an equivalent combination of relevant education and work experience.
- Five years of related work experience.
- One year of leadership experience.
- Strong verbal, written, and interpersonal communication skills with clients and internal and external staff.
- Excellent project management skills.
- High accuracy and attention to detail.
- Excellent problem-solving skills and ability to resolve problems in a timely manner.
- Ability to work independently and collaboratively in a multidisciplinary team.
- Excellent organization and prioritization skills.
- Advanced knowledge of pharmacovigilance.
- Advanced knowledge of PV systems, such as Oracle Argus Safety, ARISg, or other safety databases.
- Self-motivation to maintain efficiency and productivity and manage multiple projects and clients.
Nice To Haves
- An advanced degree, RN, RPh, PharmD, or equivalent.
- One year of people management experience.
Responsibilities
- Provide oversight and direction as a PV subject matter expert to enhance client service internally and externally.
- Supervise workload, 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 to provide training feedback and ensure compliance with regulatory requirements.
- Maintain and update work instructions, training materials, and templates.
- Identify and address PV staff training needs and ensure staff 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, which may include processing cases, quality-checking cases, assisting with the inbox, or other case-processing activities.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
