Senior Director of ICSR

Medicine moves forward here. So will you.

At Prime Vigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

POSITION SUMMARY:Manages ICSR Management Unit for assigned staff and ensures all unit-relevant activities are delivered within agreed extent. Contributes to achieving company´s goals and objectives. Performs project budget reviews, and provides support to, and management of, the Associate Directors, ICSR. Other responsibilities include independent analysis of workload, productivity and utilization of resources and their appropriate redistribution to ensure performance of the highest quality as well as coordination with other departments for all activities related to the ICSR Management Unit.

Strong experience in post marketing and clinical processing and staff management required.

Role and Responsibilities:

• Managing the assigned ICSR Management Unit effectively
• Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation
• Setting productivity targets for ongoing projects and reviewing proposed target updates as required
• Based on reports and analyses, defining the appropriate reallocation of resources in ICSR Management Unit, or working with the resourcing unit for reallocation to and from other units and departments
• Managing Associate Directors and oversight ofall employees to ensure they are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessary
• Notifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations
• Proposing the necessary changes within the project team processes to ICSR leadership
• Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit
• Training and mentoring of ICSR Line Managers and senior staff.
• Preparing various analyses and reports
• Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicable
• Supporting the Business/Commercial team during development of contracts and proposals, as applicable
• Supporting the Operations and Project Analytics team, as applicable
• Assisting HR in employee recruitment, performance evaluation, promotion, retention and termination activities
• Reviewing and approving all Critical CAPAs from the ICSR Management Unit
• Reviewing and addressing any requests from Quality department regarding ICSR Management Unit
• Reviewing and updating Prime Vigilance operating procedures and guidelines, as applicable

Education, qualifications and professional memberships:Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
-Intermediate.

EXPERIENCE: Extensive experience in pharmacovigilance case processing including post marketing, clinical and ideally medical devices. Demonstrated leadership experience at a senior level.

SPECIAL SKILLS (Advanced):

• Excellent communication (written and verbal) skills
• Excellent organization skills, including attention to details and multitasking
• Excellent management skills, including delegation skills, time and issue management
• Technical skills

PC

SKILLS:

Advanced literacy (MS Office)
-Advanced:

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to…