Quality & Compliance Lead - Pharmacovigilance (Remote)
Raleigh, NC
Job Id:
103473
Job Category:
Clinical Research
Job Location:
Raleigh, NC
Security Clearance:
None
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Peter Buechner
Piper Companies is currently seeking a Pharmacovigilance Quality & Compliance Lead (GVP) to join a global biopharmaceutical company focused on the advancement of biologics in the neurology and immunology space. The Pharmacovigilance Quality & Compliance Lead (GVP) will be responsible for implementing the pharmacovigilance strategy and leading the delivery of the audit program for the quality and compliance of the PV Systems.
Responsibilities of the Pharmacovigilance Quality & Compliance Lead (GVP):
· Lead and conduct the development of risk-based Pharmacovigilance audit program supporting clinical safety and Pharmacovigilance activities
· Conduct and report on REMS audits of Specialty Pharmacies, Specialty Distributors and program vendors, as well as internal systems audits for REMS Compliance
· Manage audit findings, responses and CAPAs
Qualifications of the Pharmacovigilance Quality & Compliance Lead (GVP):
· 5+ years’ experience in pharmacovigilance and clinical audits
· Proficiency in internal auditing, partner auditing, risk assessments, compliance monitoring, and inspection management activities preferred.
· In depth knowledge and understanding of Pharmacovigilance systems in the pharmaceutical industry
· Strong organizational and communication skills with the ability to prioritize and problem-solve
· Bachelor’s Degree or equivalent required (scientific discipline preferred)
Compensation for the Pharmacovigilance Quality & Compliance Lead (GVP):
· Salary Range: $80/hr - $95/hr based on experience
· Comprehensive benefits including Medical, Dental, Vision, sick leave if required by law, and 401k
This job opens for applications on 7/17/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: Global Quality Lead, GQL, Pharmacovigilance, PV, GVP, GQP, GXP, REMS, Clinical Development, Regulatory, Regulatory Affairs, Clinical Operations, Biologics, Clinical Research, Clinical Trials, Pharma, Sponsor, Specialty Pharmaceuticals, Specialty Pharmacy, Biopharmaceutical, Biopharma, Pharmaceutical, Pharma, Neurology, Immunology, Therapeutics, Health, Dental, Vision, Retirement, Benefits, Hybrid, Remote
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