Senior Pharmacovigilance Officer, Team Lead – Medical Device Experience

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 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 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 • 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

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • Strong previous work experience in pharmacovigilance with minimum 1 year of work experience in line manager role • Medical Device experience required • Excellent communication (written and verbal) skills • Organization skills, including attention to details and multitasking • Delegation skills • Planning and time management • Technical skills • Team working • English – fluent (spoken, written) • Advanced literacy (MS Office)

🏖️ Benefits

• The chance to keep growing while you help protect patients • A passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting • An environment built on kindness, flexibility, growth, and belonging