Pharmacovigilance Compliance Lead

Job Summary

A company is looking for a Pharmacovigilance Quality & Compliance Lead.

Key Responsibilities

• Provide quality oversight to the Pharmacovigilance System and ensure compliance with Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP)
• Support Phase IV study types and patient-centric initiatives, ensuring compliance of PV outputs such as ICSR, DSUR, and RMPs
• Develop and execute a comprehensive Quality Assurance strategy for critical PV processes and monitor compliance with global regulatory requirements

Required Qualifications

• Bachelor's degree in Life Sciences; Master's degree is a plus
• 8 - 10 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry
• Proficiency in internal auditing, partner auditing, risk assessments, and compliance monitoring
• Knowledge of GVP and GCP, and applicable regulatory frameworks
• Ability to lead medium to high complexity projects