Senior Manager, Pharmacovigilance Quality Assurance Audit - Remote

Overview

The Senior Manager, Pharmacovigilance Quality Assurance Audit is primarily responsible for executing the Pharmacovigilance audit program, ensuring compliance with worldwide regulations and AbbVie policies.

In Short

• Execute the Pharmacovigilance audit program.
• Ensure compliance with worldwide PV requirements.
• Lead the development of the PVQA quality system.
• Plan and execute PV audits.
• Support PV inspections and resolve findings.
• Promote continuous education on PV regulations.
• Analyze PV compliance data.
• Collaborate with business partners for compliance solutions.
• Contribute to the development of quality strategies.
• Participate in the continuous improvement of PV systems.

Requirements

• Bachelor’s degree in science or healthcare profession.
• 5 years of experience in the biopharmaceutical industry.
• 5 years of experience in Quality Assurance or Pharmacovigilance.
• Strong analytical and organizational skills.
• Understanding of quality systems and auditing standards.
• Knowledge of PV regulatory requirements.
• Project management and communication skills.
• Willingness to perform international travel.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off including vacation and holidays.
• Participation in short-term and long-term incentive programs.