Senior Pharmacovigilance Manager

• Lead and oversee complex pharmacovigilance projects
• Ensure high-quality service delivery in line with regulatory requirements and client expectations
• Serve as the main point of contact for key PV initiatives and important client projects
• Provide senior-level guidance, mentorship, and supervision to junior PV colleagues and project teams
• Contribute to department strategy, processes, and quality standards
• Take full responsibility for delivery of complex PV services, including strategic oversight, planning, and coordination of cross-functional PV activities
• Author or review PV documents according to client specifications, project instructions, internal rules, and applicable legislation
• Participate in development and maintenance of the iVigee quality management system
• Prepare internal SOPs, working instructions, and client SOPs
• Ensure compliance of PV activities with legislation and internal and client procedures
• Participate in or lead interactions with regulatory authorities, inspections, and audit responses
• Act as audit coordinator during vendor qualification audits, client service audits, regulatory inspections, and client audits of iVigee PV services
• Deputize in accordance with the internal responsibility matrix
• Promote knowledge sharing and best practices across PV project teams
• Represent the PV department in cross-functional initiatives and management-level meetings
• Maintain current awareness of PV legislation and regulatory guidance
• Mentor, support, and train junior PV team members
• Provide input into individual development and performance management
• Participate in building systems for medical device vigilance and cosmetovigilance
• Support other PV activities as requested

• University degree in medicine, pharmacology, life sciences or other healthcare professional fields
• 5+ years of experience directly in pharmacovigilance
• Pharmacovigilance System Master File (PSMF) authoring and management
• Local PV Network management
• Coordination and management of additional Risk Minimisation Measures (aRMM) — an advantage
• EU QPPV or Deputy EU QPPV role — an advantage
• Managerial and organization skills
• Communication skills
• Presentation skills
• Team working
• Ability to motivate people and leadership
• Fluent English
• Advanced literacy in Microsoft Office applications

• Good work-life balance
• Long-term relationships and lasting solutions
• Opportunity to work with AI-enabled pharmacovigilance tools and innovative technologies
• Professional development through mentorship, training, and knowledge sharing
• Participation in management-level meetings and cross-functional initiatives
• Opportunity to work with global clients and experts in over 150 countries