Company Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid‑size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first‑class support to our small to large pharmaceutical and biotechnology partners, maintaining long‑lasting relationships and has become a global leader in its field. We cover all therapy areas, including medical devices. We invest in our staff by providing an excellent training and development platform, valuing employee experience, well‑being and mental health, and fostering a healthy work‑life balance that nurtures high‑quality client service. Come and join us in this exciting journey to make a positive impact in patients’ lives.
Job Description
- Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line Manages ICSR staff
- Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
- Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
- Contributes to achieving company’s goals and objectives
- Works under supervision of ICSR Operational Lead
- Provides support to other activities undertaken by the project team on behalf of the client and the company
- Creates and maintains project specific KPIs for contracted ICSR activities (includes optimizing procedures, training and 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
- Supports other departments, as approved and instructed by ICSR Operational Lead
- Operates as the assigned team SME
- Supports 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
Qualifications
- Life science graduate, pharmacy, nursing, or other healthcare related qualification or experience in pharmacovigilance
- Strong previous work experience in pharmacovigilance, including minimum 1 year in a line manager role
- Medical device experience required
- Excellent communication (written and verbal) skills
- Organisational skills, including attention to detail and multitasking
- Delegation skills
- Planning and time management
- Technical skills
- Team working
- English – fluent (spoken, written)
- Advanced literacy in MS Office
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human‑centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach – because our people are our greatest strength, leading to our continued success in improving the lives of those around us.
We Offer
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
Core Values
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
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