Pharmacovigilance & Patient Safety Vendor Management Manager

Title: Pharmacovigilance & Patient Safety Vendor Management Manager

Location: Plainsboro, NJ (Onsite)

Employment Type: Contract – 6 Months

Status: Accepting Candidates

About the Role

Support Patient Safety and Pharmacovigilance operations through vendor oversight, contract management, and compliance with safety reporting requirements. Partner with internal teams and external suppliers to ensure adherence to Pharmacovigilance Agreements (PVAs) and applicable regulatory requirements.

Key Responsibilities

• Manage vendor contracts and Pharmacovigilance Agreement (PVA) requirements for patient safety programs and suppliers.
• Oversee safety information reconciliation and quality control activities to ensure compliance with PVA requirements.
• Coordinate with Patient Safety, Quality Assurance, Legal, Compliance, Finance, and external business partners.
• Investigate late safety reports and support root cause analysis, corrective actions, and preventive actions (CAPA).
• Support audit and inspection readiness, pharmacovigilance SOP maintenance, and regulatory compliance.
• Provide guidance and training on vendor management, contracts, and safety reporting requirements.

Qualifications

• Bachelor's degree in Medical or Life Sciences with at least 8 years of relevant pharmacovigilance experience, or healthcare professional qualification (e.g., RN or R.Ph.) with at least 5 years of experience, including 3 years in safety reporting.
• Knowledge of FDA requirements, safety information reporting, and applicable regulations and SOPs.
• Experience with Pharmacovigilance Agreements (PVAs) and patient safety reporting processes.
• Pharmaceutical industry experience in contract management or alliance management preferred.
• Strong project management and organizational skills, with the ability to manage multiple priorities and deadlines.
• Proficiency in Microsoft Word, Excel, and PowerPoint.