Pharmacovigilance jobs in United States

PLG is seeking a dedicated Pharmacovigilance Specialist - Case Processing to join our hub. The role involves overseeing and collaborating closely with our PV team to ensure compliance with regulatory standards and the accuracy of safety data.

1. Serve as the key trainer for junior team members to enhance quality and expand knowledge of PV case processing.
2. Review cases and identify areas for improvement.
3. Provide expertise and act as SME for the team, ensuring understanding of tasks by case management team.
4. Manage larger client projects and act as the single point of contact for clients.
5. Monitor client KPIs.
6. Support in resolving NC/CAPA, identify RCA, and implement improvements.
7. Perform Quality Control/Medical Review and support the team to ensure regulatory compliance.
8. Participate in audits and inspections as required.
9. Ensure understanding of client needs and meet or exceed expectations.
10. Organize team meetings as needed.

• Pharmacy graduate.
• Minimum 5-10 years experience working for service providers, with previous experience in data entry, management, or pharmacovigilance (preferably 5+ years).

• Proficiency in Microsoft Office and familiarity with PV databases (e.g., Argus, ArisG).

• Understanding of GVP and regulatory standards related to pharmacovigilance.

• Sense of priorities.
• Team management.
• Organization skills.
• Team spirit.
• Methodical approach.
• Strong communication skills.
• Decision-making ability.
• Rigour.
• Adaptability.
• Proficiency in Microsoft Office.
• Fluent in both English and French (oral and written).