Requirements & Experience:

• Oversee processing and medical review of adverse event cases
• Ensure compliance with EU and global regulatory timelines
• Perform signal detection, evaluation, and documentation
• Contribute to safety reports PSURs, DSURs, RMPs
• Support preparation and maintenance of the PSMF
• Act as a subject-matter expert for pharmacovigilance activities
• Liaise with regulatory authorities and business partners
• Support inspections, audits, and CAPA implementation
• Train and mentor junior pharmacovigilance staff
• Contribute to continuous improvement of PV processes