EPM Scientific · 1 month ago
Manager Pharmacovigilance Specialist
Somerset, NJ
Full-time
Hybrid
Mid, Senior Level
$120K/yr - $150K/yr
4+ years expEPM Scientific is seeking an experienced healthcare professional with pharmacovigilance expertise to join their team. The role involves managing pharmacovigilance operations, ensuring compliance with regulatory requirements, and supporting risk management initiatives.
BiotechnologyRecruiting
Hiring Manager
Adam Kong
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
Qualification
Required
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
Regulatory experience
Ability to build collaborative relationships across all levels and geographies
Strategic thinker with a commitment to continuous learning and improvement
Benefits
Discretionary performance bonus
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
BioSpectrum Asia
2023-12-23
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