Director of ICSR & Pharmacovigilance Operations

PrimeVigilance Ltd.; Roma; In loco; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

PrimeVigilance Ltd. is seeking a senior ICSR Program Manager to lead the ICSR Management Unit, oversee staff and resources, and ensure high-quality pharmacovigilance deliverables.

The role emphasizes strong leadership, budget awareness, and cross-functional collaboration to support regulatory compliance and client needs. The ideal candidate has extensive pharmacovigilance experience, proven senior leadership abilities, and a record of driving efficiency and quality in post-marketing safety

Competenze

• Extensive experience in pharmacovigilance case processing including post marketing and clinical processing.
• Demonstrated leadership experience at a senior level.

Mansioni

• Manage the assigned ICSR Management Unit effectively.
• Ensure adequate resources within the ICSR project teams to achieve productivity.
• Set productivity targets for ongoing projects and review targets.
• Reallocate resources based on reports to optimize performance.
• Oversee Associate Directors and staff utilisation across ICSR leads/teams.
• Coordinate with Resourcing for additional resource needs and budget approvals.
• Drive process improvements and best practices within the unit.
• Mentor and train ICSR line managers and senior staff.
• Prepare analyses and reports for oversight bodies.
• Support development of contracts and proposals as needed.
• Assist HR in recruitment and evaluation activities.
• Review and approve all Critical CAPAs from the unit.
• Address QA requests related to the ICSR unit.

Conoscenze

Excellent communication

Excellent organization

Excellent management

Technical skills

Team working

Formazione

Life science degree / healthcare qualification

Strumenti

MS Office

Descrizione del lavoro

PrimeVigilance Ltd. is seeking a senior ICSR Program Manager to lead the ICSR Management Unit, oversee staff and resources, and ensure high-quality pharmacovigilance deliverables.

The role emphasizes strong leadership, budget awareness, and cross-functional collaboration to support regulatory compliance and client needs. The ideal candidate has extensive pharmacovigilance experience, proven senior leadership abilities, and a record of driving efficiency and quality in post-marketing safety