[Hiring] Senior Pharmacovigilance Manager @iVigee

Role Description

• To lead and oversee complex pharmacovigilance (PV) projects, ensuring high-quality service delivery in line with regulatory requirements and client expectations.
• To serve as the main point of contact for key PV initiatives and important client projects.
• To provide senior-level guidance, mentorship, and supervision to junior PV colleagues and project teams.
• To contribute to the development and implementation of department strategy, processes, and quality standards.

Qualifications

• 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.

Requirements

• Managerial and organization skills.
• Communication skills.
• Presentation skills.
• Team working.
• Ability to motivate people, leadership.
• English (fluent).
• Advanced literacy (Microsoft Office applications).

Benefits

• Full responsibility for the delivery of complex PV services to clients, including strategic oversight, planning, and coordination of cross-functional PV activities.
• Authoring or review of PV documents in compliance with the client´s specification, project-specific instruction, internal working rules, and applicable legislation.
• Participation in iVigee quality management system development and maintenance, preparation of internal SOP/working instructions, and preparation of client’s SOPs.
• Compliance of PV activities with legislation, internal and client’s procedures.
• Participate in or lead interactions with regulatory authorities, including inspections and audit responses; act as audit coordinator during vendor qualification audits, audits conducted as a service for clients, inspections by regulatory authorities, or audits performed by clients on iVigee’s PV services.
• Effective deputizing in accordance with the internal responsibility matrix.
• Promote knowledge sharing and best practices across PV project teams.
• Actively participate in management-level meetings and represent the PV department in cross-functional initiatives.
• Maintain current awareness of PV legislation and regulatory guidance and apply it to strategic decision-making.
• Mentor, support, and train junior PV team members; provide input into individual development and performance management.
• Be open to new areas of vigilance (e.g., medical device vigilance, cosmetovigilance) and participate in building relevant systems.
• Support other PV activities as requested.