Pharmacovigilance Manager, Case Processing

ProPharma Group; United States; Hybrid; USD 120,000 - 160,000; Full time

Job summary

ProPharma Group is seeking a Pharmacovigilance Manager, Case Processing to oversee PV staff and ensure high-quality adverse event case processing. You will coordinate intake, review cases for regulatory compliance, and act as the client contact for case management communications.

The role requires a Bachelor’s in life sciences, 5+ years PV experience, and 1+ year leadership, with expertise in Oracle Argus Safety or ARISg. Hybrid remote work is available across the US.

Qualifications

• Bachelor's degree in life sciences or equivalent.
• 5+ years of pharmacovigilance experience.
• 1+ year of leadership experience.
• Experience with PV systems such as Oracle Argus Safety and ARISg.
• Strong communication and project management skills.

Responsibilities

• Provide PV staff oversight and perform case processing quality reviews.
• Coordinate adverse event intake and case processing per guidelines.
• Serve as client contact for case management communications.
• Develop and improve PV processes, templates and training materials.
• Mentor staff and manage staffing, scheduling, and training needs.
• Support client implementation meetings and guideline explanations.
• Manage billable activities to meet utilization targets as assigned.

Skills

PV knowledge

Leadership

Project management

Communication

Regulatory compliance

Education

Bachelor's degree in life sciences

Tools

Oracle Argus Safety

ARISg

PV databases

Job description

For the past 25 years, ProPharma 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. ProPharma 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, ProPharma 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 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.Educational Requirements:Required: a Bachelor's degree in life sciences or an equivalent combination of relevant education and work experience.Preferred: an advanced degree, RN, RPh, PharmD or equivalent.Experience Requirements:Required: five years of related work experience.Required: one year of leadership experience.Preferred: one year of people management experience.#LI-KP1#LI-REMOTEWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***