Senior Pharmacovigilance Case Processing Lead

Ergomed; Województwo mazowieckie; On-site; PLN 180,000 - 240,000; Full time

Job summary

Ergomed Group in Poland is seeking a pharmacovigilance professional to lead ICSR activities within our RA & PV network. You will manage ICSR processing, perform 2nd QC of cases, and act as the SME for the team.

This role requires a life science or healthcare qualification and 5–6 years in pharmacovigilance, including line management. Strong communication, organization, and MS Office skills are essential to mentor staff and drive KPI improvements.

Qualifications

• Life science or healthcare qualification and experience in pharmacovigilance.
• Experience in ICSR processing and PV operations is preferred.
• Strong communication and organizational skills.

Responsibilities

• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Line Manages assigned ICSR staff
• Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
• Proposes process changes to ICSR Operational Lead
• Manages ICSR deviations with ICSR Operational Lead support
• Reviews trackers and timesheet data and ensures accuracy
• Is involved in ICSR processing and 2nd QC of cases
• Support other departments, as approved and instructed by ICSR Operational Lead
• Operates as the assigned team SME and supports other SMEs
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Skills

Pharmacovigilance

Line management

Communication

Organization

Delegation

Planning

Technical skills

Teamwork

English fluent

MS Office

Education

Healthcare degree

Job description

Ergomed Group in Poland is seeking a pharmacovigilance professional to lead ICSR activities within our RA & PV network. You will manage ICSR processing, perform 2nd QC of cases, and act as the SME for the team.

This role requires a life science or healthcare qualification and 5–6 years in pharmacovigilance, including line management. Strong communication, organization, and MS Office skills are essential to mentor staff and drive KPI improvements.