Pharmacovigilance Manager Case Processing

ProPharma; Philippines; Hybrid; PHP 1,200,000 - 1,800,000; Full time

Job summary

ProPharma, a longstanding healthcare consulting firm, seeks a Pharmacovigilance (PV) Leader to oversee PV activities and team performance. You will guide case processing, compliance, and training while supporting client implementations and maintaining PV systems.

Required: bachelor's degree with five years of PV experience and at least one year in a leadership role. Familiarity with Oracle Argus Safety or ARISg is essential.

Qualifications

• Bachelor's degree required.
• Minimum five years of pharmacovigilance experience.
• One year of leadership experience preferred.
• Experience with PV systems such as Oracle Argus or ARISg is required.

Responsibilities

• Provide PV SME oversight and direction.
• Supervise workload, provide performance feedback, conduct reviews.
• Lead, coach, mentor, and motivate staff for optimal performance.
• Make decisions aligned with company policies and guidelines.
• Handle staffing: hiring, scheduling, and training.
• Foster teamwork and communicate needs to management.
• Review cases for training feedback and regulatory compliance.
• Maintain training materials, SOPs, and templates.
• Identify training needs for PV staff and ensure competency.
• Contribute to process and workflow improvements.
• Support client implementations and guideline explanations.
• Engage in billable work to meet utilization targets.

Skills

PV Knowledge

Argus Safety

ARISg

Communication

Project Management

Detail Orientation

Leadership

Education

Bachelor's degree

Tools

Oracle Argus

ARISg

Job description

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.

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.

Experience Requirements:

• Required: five years of related work experience.


• Required: one year of leadership experience.


• Preferred: one year of people management experience.

#LI-FDT1

We 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.***