Senior Specialist, Local Pharmacovigilance

About the role

The Senior Specialist, Local Pharmacovigilance will lead the establishment and management of the local pharmacovigilance (PV) system. You will work closely with global PV teams, regulatory authorities, and internal stakeholders to ensure safety monitoring and compliance for products in the assigned country or region.

Key responsibilities

• Set up and oversee the local PV system, including literature searches, ICSR collection, and PV intelligence screening.
• Maintain the local PSMF, organize data collection, and manage local PV activities.
• Prepare and submit local PSUR/RMP documents and conduct signal detection where applicable.
• Implement risk‑minimization measures and review post‑authorization safety study materials.
• Participate in PV‑related audits, inspections, and provide monthly PV status reports.
• Deliver PV training to affiliate employees, service providers, and third parties.
• Issue, review, and maintain PV procedures in alignment with global standards.
• Act as the official liaison with the competent authority, ensuring 24/7 availability for safety matters.
• Coordinate national safety communications and ensure timely notification of significant safety concerns.

Required profile

• Bachelor’s degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field.
• 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 the local language.

Required skills

What we offer

• Opportunity to work within an innovative global health company dedicated to improving lives of people and animals.
• Collaborative environment with close cooperation between local and global PV teams.