Pharmacovigilance Manager, Case Processing

For the past 25 years, Pro Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. Pro Pharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro Pharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Pharmacovigilance (PV) Manager, Case Processing supervises PV staff and provides oversight to pharmacovigilance activities, processes and procedures including pharmacovigilance case processing and assessment. The PV Manager provides oversight for adverse event intake and case processing, ensures PV activities are processed consistent with internal guidelines, SOP’s, and Global Safety regulations. The PV Manager collaborates with other PV management to coordinate, develop and maintain all aspects of Pro Pharma’s pharmacovigilance services.

The PV Manager acts as client contact for case management communications, participates in the development and continuous improvement of processes, workflow, and supporting documents. The PV Manager maintains distinctive quality and commitment as the operating philosophy in carrying out all processes, and continually seeks out ways to enhance customer service experience both internally and externally.

Essential Functions:

Provide oversight and direction as a PV subject matter expert, enhancing client service internally and externally. Supervise workload, offer ongoing performance feedback, and conduct annual reviews. Demonstrate leadership, coach, mentor, and motivate staff for 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 training needs for PV staff, ensuring competency for assigned duties. Contribute to the development and continuous improvement of processes, SOPs, and workflow. Support client implementation, including meetings, guideline creation, and process explanation. Perform billable work to adhere to target utilization as set by line manager based on span of control.

Billable activities may include processing cases, QC cases, assisting with the inbox, or other case processing activities. Other duties as assigned. Necessary

Skills and Abilities:

Strong verbal, written and interpersonal communication skills with clients, external and internal staff. Excellent project management skills. High level of accuracy and attention to detail. Excellent problem-solving skills and ability to resolve problems in a timely manner. Able to work independently and collaboratively in a multi-disciplinary team. Excellent organization and prioritization skills with attention to detail. Advanced Knowledge of Pharmacovigilance. Advanced knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.

Self-motivated to maintain high efficiency and productivity levels and manage multiple projects and clients.

Educational Requirements:

Required:

a Bachelor's degree in life sciences or an equivalent combination of relevant education and work…