Senior Director of ICSR

PrimeVigilance Ltd.; Lisbon (AR); On-site; USD 120,000 - 160,000; Full time

Job summary

PrimeVigilance Ltd. is seeking an experienced leader to manage the ICSR Management Unit and mentor senior staff. You will oversee resource planning, budgeting, and cross‑department coordination to ensure high‑quality pharmacovigilance processing across post‑marketing and clinical activities.

The role requires strong communication, organizational, and problem‑solving skills, with a track record of leadership in pharmacovigilance. This is a senior, on‑site position within a global team.

Qualifications

• Life science graduate or healthcare qualification with pharmacovigilance experience.
• Extensive experience in pharmacovigilance case processing including post marketing and clinical.
• Demonstrated senior-level leadership experience.

Responsibilities

• Manage the assigned ICSR Management Unit effectively.
• Ensure adequate resources within ICSR project teams to maximize productivity.
• Set productivity targets for ongoing projects and review updates.
• Reallocate resources based on reports and analyses for ICSR units.
• Oversee Associate Directors and staff utilization; reallocate as needed.
• Notify Resourcing about needs for additional resources and open requests.
• Propose process changes to ICSR leadership to improve efficiency.
• Identify and implement best practices to boost productivity.
• Train and mentor ICSR Line Managers and senior staff.
• Prepare analyses and reports for leadership and stakeholders.
• Review budgets and allocations for new projects and scopes.
• Support Business/Commercial during contracts and proposals.
• Support Operations and Project Analytics as applicable.
• Assist HR in recruitment, performance evaluation, promotions, retention and terminations.
• Review and approve Critical CAPAs from ICSR Unit.
• Coordinate with Quality on ICSR requests.
• Update PrimeVigilance procedures and guidelines.
• Support business development activities.

Skills

Excellent communication

Excellent organization

Excellent management

Technical skills

Team working

Education

Life science graduate

Pharmacy

Nursing

Other healthcare qualification or experience in pharmacovigilance

Tools

MS Office

Job description

Company Description

Medicine moves forward here. So will you.

At PrimeVigilance, 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.

Job Description

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 PrimeVigilance operating procedures and guidelines, as applicable
• Business development activities

Qualifications

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
• Team working

PC SKILLS:Advanced literacy (MS Office) -Advanced:

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.

• Integrity and trust: we do the right thing, especially when it is hard.

• Drive and passion: we care about the outcome, because someone is waiting on it.

• Agility and responsiveness: we move quickly, because patients cannot wait.

• Belonging: everyone is welcome, and every voice counts.

• Collaborative partnerships: we go further by going together.