Senior Pharmacovigilance Manager

Ivigee; United States; A distancia; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

Ivigee is seeking an experienced pharmacovigilance leader to oversee complex PV projects and act as the primary contact for key client initiatives. The role includes senior-level guidance and mentoring of junior PV colleagues, with a focus on delivering high-quality PV services in compliance with regulatory requirements.

The successful candidate will contribute to department strategy and quality standards while promoting best practices across PV project teams and coordinating with

Formación

• Bachelor-level or higher degree in a life sciences or healthcare field; strong leadership and mentoring capabilities.
• Excellent written and spoken communication skills; ability to present to executives and clients.
• Ability to coordinate cross-functional teams and drive PV projects to conclusion.

Responsabilidades

• Lead and oversee complex pharmacovigilance (PV) projects with strategic oversight and cross-functional coordination.
• Author or review PV documents per client specifications, internal rules, and applicable legislation.
• Contribute to PV department strategy, processes, and quality standards; mentor junior team members.

Conocimientos

Management

Communication

Presentation

Teamwork

Leadership

Educación

University degree in medicine, pharmacology, life sciences or other healthcare professional fields

Herramientas

MS Office

Descripción del empleo

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:

Education

• University degree in medicine, pharmacology, life sciences or other healthcare professional fields

Experience

• 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

Special skills

• Managerial and organization skills
• Communication skills
• Presentation skills
• Team working
• Ability to motivate people, leadership

Language skills

• English (fluent)

Computer skills

• Advanced literacy (Microsoft Office applications)