Senior Pharmacovigilance Manager

Purpose of the job position:

·      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

MAJOR TASKS AND RESPONSIBILITIES:

·      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

Specific requirements for the position: