PV Auditor (Pharmacovigilance Audit Specialist) – Remote Contract Role | ProPharma Careers
About ProPharma
ProPharma is a global consulting organization with over 20 years of experience supporting pharmaceutical, biotechnology, and medical device companies. Through its advise-build-operate model, ProPharma delivers integrated solutions across regulatory sciences, clinical research, pharmacovigilance, quality & compliance, medical information, and R&D technology. The organization partners with clients to de-risk development programs and accelerate the delivery of safe and effective therapies to patients worldwide.
Job Overview
ProPharma is seeking an experienced Pharmacovigilance (PV) Auditor to support global audit activities within pharmacovigilance systems and processes. This is a remote contract opportunity requiring strong expertise in PV compliance, regulatory inspections, and audit execution. The role involves both full-time engagement for an initial 4–6 weeks and part-time/consulting support throughout the remainder of the year, as required.
Job Location & Work Model
Work Type: Remote (Contract-based)
Initial Engagement: Full-time for 4–6 weeks
Ongoing Support: Part-time / as-needed basis throughout the year
Key Responsibilities
Conduct pharmacovigilance system and process audits in alignment with global regulatory requirements
Evaluate compliance with PV regulations, including FDA, EMA, ICH guidelines, and applicable global standards
Assess pharmacovigilance systems, SOPs, and quality management frameworks
Identify audit findings, gaps, and compliance risks
Prepare detailed audit reports with observations and corrective action recommendations
Support inspection readiness activities and regulatory inspections when required
Review PV processes such as case processing, safety reporting, signal management, and literature monitoring
Collaborate with cross-functional teams to ensure implementation of CAPA (Corrective and Preventive Actions)
Provide expert guidance on PV compliance and audit best practices
Required Skills and Competencies
Strong expertise in pharmacovigilance auditing and compliance systems
Deep understanding of global PV regulations (FDA, EMA, ICH-GVP)
Experience in conducting internal, vendor, or system audits in pharmacovigilance
Strong analytical and risk assessment capabilities
Excellent report writing and documentation skills
Ability to work independently in a remote consulting environment
Strong communication and stakeholder management skills
Detail-oriented with strong problem-solving abilities
Educational Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, or a related scientific discipline
Experience Requirements
Minimum: 10+ years of experience in Pharmacovigilance auditing
Required: Proven experience in PV system audits, regulatory inspections, or quality compliance functions
Preferred: Experience working with global pharmaceutical, biotech, or CRO environments
Why Join ProPharma
Opportunity to work on global pharmacovigilance audit programs
Flexible remote contract engagement
Exposure to high-impact regulatory and compliance projects
Collaborative environment with global industry experts
Participation in high-profile pharmaceutical and device programs
Diversity, Equity, and Inclusion
ProPharma is committed to fostering an inclusive workplace where diversity is valued and every individual is empowered to succeed. The company promotes innovation, collaboration, and equal opportunity across all roles.
Application Process
All applications are reviewed directly by ProPharma’s recruitment team. Candidates receive clear communication regarding their application status. ProPharma does not use AI-based screening tools in its hiring process.
Important Notice
ProPharma does not accept unsolicited resumes from third-party recruiters. Direct contact via phone or email regarding this position is not permitted.
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