Manager Pharmacovigilance Specialist
Manager, Pharmacovigilance
Location: Bridgewater, NJ (Hybrid- 4x onsite a week)
Position Overview
We are seeking an experienced and motivated healthcare professional with pharmacovigilance expertise to join our team. This role involves managing pharmacovigilance operations and ensuring compliance with U.S. and Canadian regulatory requirements. You will support risk management and REMS programs, review safety data, and collaborate across departments to uphold drug safety standards.
Key Responsibilities
- Ensure compliance with pharmacovigilance regulations and internal SOPs.
- Act as a liaison between the PV team and cross-functional stakeholders.
- Oversee the collection, evaluation, and reporting of safety data for company products.
- Implement and optimize PV processes to improve efficiency and compliance.
- Represent PV during internal and external audits and inspections.
- Develop and execute risk management strategies, including Canadian Risk Management Plans.
- Build, develop, and implement REMS programs in the U.S.
- Collaborate with global PV teams to harmonize safety practices and share best practices.
- Analyze safety data trends and escalate potential risks to senior leadership.
- Drive continuous improvement initiatives for PV operational excellence.
- Create and update SOPs and work instructions related to PV operations.
- Conduct PV training for employees and vendors to ensure regulatory compliance.
- Provide regular updates to the Director of Pharmacovigilance and REMS on performance and compliance.
- Perform other PV and risk management duties as assigned.
Qualifications
- PharmD, Physician Assistant, or Nurse Practitioner with 4+ years of pharmacovigilance experience.
- Strong problem-solving skills and ability to enforce safety rules and global procedures.
- Strong medical/scientific background
- Excellent written and verbal communication skills; fluency in English required.
- Proactive, detail-oriented, and able to meet timelines.
- High level of responsibility and accountability.
- Reglatory experience
- Ability to build collaborative relationships across all levels and geographies.
- Strategic thinker with a commitment to continuous learning and improvement.
Compensation
The anticipated salary range for this position in New Jersey is $120,000 - $150,000, plus discretionary performance bonus (based on eligibility). Final compensation will depend on factors such as experience, skills, education, and business needs.
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