Manager, Local Pharmacovigilance

About the role

The Manager, Local Pharmacovigilance will lead the establishment and operation of the local pharmacovigilance system, ensuring compliance with national regulations and supporting the global safety strategy. This role works closely with the global PV team, local affiliates, and health authorities to monitor product safety and manage risk.

Key responsibilities

• Set up and manage the local pharmacovigilance system, including oversight of all local PV activities.
• Conduct local literature searches, ICSR collection, and PV intelligence screening.
• Maintain the local PSMF, organize data collection, and manage local PV assessments.
• Prepare and submit local PSUR/RMP documents where applicable.
• Perform local signal detection and implement additional risk‑minimisation measures.
• Review materials for post‑authorization safety studies and support related audits and inspections.
• Provide monthly PV status reports and ensure PV training for affiliate staff and third‑party service providers.
• Serve as the official liaison with the competent authority, handling 24/7 availability, safety communications, and reporting of significant safety concerns.
• Maintain and update local PV procedures, SOPs, and working practices in alignment with global standards.

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 documentation control.
• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.
• Fluent business English and proficiency in Latvian, Estonian, and Lithuanian.

Required skills