Pharmacovigilance Manager, Case Processing

ProPharma; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

ProPharma is seeking a Pharmacovigilance Manager, Case Processing to supervise PV staff and oversee adverse event intake and case processing in the United States.

The role ensures compliance with internal guidelines, SOPs and Global Safety regulations, while driving process improvements and client interactions. It requires leadership experience and strong PV systems knowledge.

Qualifications

• Five years of related PV work experience.
• One year of leadership experience.
• Preferred: one year of people management experience.

Responsibilities

• 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.

Skills

Leadership

Project management

Communication

Attention to detail

Problem-solving

Teamwork

Organization

PV knowledge

PV systems

Tools

Oracle Argus Safety

ARISg

Job description

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 ProPharma’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.

Experience Requirements:

• Required: five years of related work experience.
• Required: one year of leadership experience.
• Preferred: one year of people management experience.