Senior Pharmacovigilance Specialist

About the role

The Senior Pharmacovigilance Specialist (PV) carries out specified PV activities independently, in line with applicable regulations, company policies and procedures. The role covers local PV processes across supported countries, and the PV lead may designate the specialist as the backup local Qualified Person for PV (QPPV) / local PV contact, who then manages day-to-day PV activities in the PV lead's absence under higher-level supervision.

Key responsibilities

• Execute local PV processes with internal and external partners, including local PV agreements, due diligence, PSMP implementation, aggregate safety report scheduling, local training and safety issue communication
• Manage adverse event cases: intake, translation, acknowledgments, follow-up and submission
• Support PV, business partner and vendor audits and inspections, and prepare CAPAs; support issue management and corrective actions
• Maintain local PV procedures and controlled documents (SOPs, training materials, core PV documents)
• Conduct or support PV self-inspections and prepare or maintain local RMPs for the local health authority
• Oversee local risk minimisation measures and implement business continuity plans
• Manage local literature screening and archive safety documentation
• Act as local SME on PV regulations, coordinate translations with a second-person QC check, and support the PV training matrix and onboarding plans
• Review local initiatives for PV compliance, monitor the health authority website for safety issues, and liaise with business units and external partners
• May manage direct reports, take part in special projects and complete required training on time

Required profile

• Health, life science or medical science degree or equivalent by education or experience
• At least 2 years of pharmaceutical industry experience preferred; supervisory experience preferred if managing staff
• Fluent English (written and spoken) and proficiency in the local language
• Ability to travel within the region and globally; valid driving licence

Required skills

• In-depth knowledge of adverse event reporting requirements, PV regulations and PV quality management systems
• Experience with PV audits and health authority inspections
• Adverse event reporting, compliance monitoring, corrective action management, drug safety surveillance and risk management