Manager, Local Pharmacovigilance

About the role

As a Manager, Local Pharmacovigilance you will lead the establishment and oversight of the pharmacovigilance system for a specific country or region. You will work closely with global PV teams, local health authorities, and internal stakeholders to ensure safety data are collected, assessed, and reported in compliance with national regulations.

Key responsibilities

• Set up and manage the local pharmacovigilance system, including literature search, ICSR collection, and PV intelligence screening.
• Maintain the local PSMF, organize data collection, and manage local PV activities such as PSUR/RMP submissions and signal detection.
• Coordinate risk minimisation measures, post‑authorization safety studies, and safety communications.
• Participate in PV‑related audits, inspections and provide monthly status reports.
• Deliver PV training to affiliate employees, service providers and third parties.
• Serve as the official liaison with the national Competent Authority and ensure timely notification of safety concerns.
• Develop, review and maintain local SOPs and working practices aligned with global procedures.

Required profile

• Bachelor’s degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management or a related field (or equivalent experience).
• Minimum 2 years of experience in regulatory affairs, quality assurance, compliance or related areas.
• Certification in regulatory affairs, quality management or auditing is preferred.
• Fluent in business English and the local language.

Required skills

• Pharmacovigilance system management.
• Regulatory compliance and documentation control.
• Risk‑minimisation and signal‑detection processes.
• Audit and inspection support.
• SOP development and maintenance.

What we offer

• Competitive benefits package (varies by location).