Job Title: Pharmacovigilance Audit and Inspection Readiness Expert
📍 Locations:
Cambridge, Massachusetts, USA
Morristown, New Jersey, USA
💰 Salary Range: USD 125,250 – 180,916.66
About Sanofi
At Sanofi, curiosity meets cutting-edge innovation. Across oncology, rare diseases, neurology, and vaccines, our teams work at the intersection of laboratory science and AI-powered discovery to transform breakthrough ideas into real-world impact.
We are a global healthcare company with one clear purpose — to chase the miracles of science to improve people’s lives. Here, you’ll find countless opportunities to grow your expertise, leadership, and global impact.
About the Role
The Pharmacovigilance (PV) Audit and Inspection Readiness Expert ensures Sanofi’s global PV system remains inspection-ready and compliant with GxP and regulatory requirements.
This role plays a critical part in maintaining continuous inspection preparedness across global and local PV offices, managing regulatory interactions, and supporting global audit and CAPA management processes.
Key Responsibilities
1. Inspection & Audit Readiness
Ensure permanent inspection preparedness of Global PV and Country PV offices for regulatory inspections and audits.
Actively participate in GxP regulatory inspections—from preparation to follow-up and closure.
Coordinate support for Global Quality audits and Business Partner audits impacting PV processes, systems, or affiliates.
2. CAPA Management
Monitor CAPA (Corrective and Preventive Actions) related to PV audits/inspections to ensure timely completion and effectiveness.
Collaborate with CAPA owners to ensure preventive measures are sustainable and recurrence is avoided.
3. Business Partner & Vendor Oversight
Manage PV audit activities for Business Partners and Global Service Providers, in collaboration with external auditors and internal GPV functions.
4. Quality Oversight & Country Support
Act as PV Quality Liaison for assigned countries, providing oversight and guidance to Country Safety Heads.
Identify and escalate PV Quality risks, issues, and mitigation plans to Regional PV/Quality Heads.
5. Regulatory & External Relations
Support interactions with Health Authorities, Inspectorates, and Pharma Associations.
Monitor and benchmark evolving PV inspection trends, regulations, and best practices across global networks.
About You
Education
🎓 Bachelor’s or higher in one of the following:
Pharmacy (BPharm, RPh, Pharm D)
Nursing (BSN, BScN)
Biological/Health Sciences or related field
Experience
Minimum 5 years in Pharmacovigilance or clinical field (preferably in Quality Management).
Minimum 7 years in the global pharmaceutical industry, including post-marketing and clinical development.
Proven experience working across global, multicultural environments.
Skills & Competencies
Strong inspection and audit management expertise in PV.
Excellent knowledge of international PV regulations (ICH, CIOMS, EU GVP, FDA).
Outstanding communication and organizational skills under pressure.
Collaborative team player with cross-functional leadership ability.
Ability to interact constructively with inspectorates and regulators.
Fluency in Spanish preferred (for LATAM region inspections).
Why Choose Sanofi
🌍 Work at the forefront of science, safety, and innovation in a truly global organization.
📈 Access endless career growth opportunities—locally and internationally.
💎 Receive a competitive rewards package that recognizes your contributions.
🩺 Comprehensive health, wellness, and prevention programs for you and your family.
👶 Enjoy at least 14 weeks of gender-neutral parental leave.
Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers committed to diversity and inclusion.
All qualified applicants are considered without regard to race, color, religion, sex, gender identity, national origin, age, sexual orientation, disability, veteran status, or other protected characteristics.
Tags
#Pharmacovigilance #AuditReadiness #InspectionManagement #GxPCompliance #QualityManagement #GlobalPV #GD-SG #LI-GZ #LI-Onsite #vhd
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