PV Officer, Team Lead

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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 • 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 • 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 • Operates as the assigned team SME and supports other SMEs

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • Extensive experience in pharmacovigilance within which demonstrated work experience in line manager role • Excellent communication (written and verbal) skills • Organization skills, including attention to details and multitasking • Delegation skills • Planning and time management • Technical skills • Team working • Fluency in English and Japanese

🏖️ Benefits

• Training and career development opportunities internally • Strong emphasis on personal and professional growth • Friendly, supportive working environment • Opportunity to work with colleagues based all over the world, with English as the company language