Senior Pharmacovigilance Officer, Team Lead – Case Processing Manager, Medical Device Experience

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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

• Lead the team responsible for ICSR management for selected projects or groups of projects • Line manage ICSR staff • Distribute tasks for assigned projects and teams and oversee workflow processes • Foster effective cooperation with clients in ICSR Management • Contribute to company goals and objectives • Provide support to project team activities on behalf of clients and the company • Create and maintain project-specific KPIs for contracted ICSR activities • Optimize procedures, training, and other actions to improve ICSR team efficiency • Propose process changes to the ICSR Operational Lead • Manage ICSR deviations with support from the ICSR Operational Lead • Review trackers and timesheet data and ensure accuracy • Participate in ICSR processing and second quality control of cases • Support other departments as approved and instructed by the ICSR Operational Lead • Operate as the assigned team subject matter expert • Support the RA & PV Network Department as needed • Act as the LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

🎯 Requirements

• Life science graduate, pharmacy, nursing, another healthcare-related qualification, or experience in pharmacovigilance • Strong previous work experience in pharmacovigilance • Minimum 1 year of work experience in a line manager role • Medical Device experience required • Excellent written and verbal communication skills • Organization skills, including attention to detail and multitasking • Delegation skills • Planning and time management skills • Technical skills • Team working skills • Fluent English, spoken and written • Advanced literacy in MS Office

🏖️ Benefits

• Remote work • Flexible work environment • Growth opportunities • Collaborative team environment • Supportive culture focused on kindness, flexibility, growth and belonging • Opportunity to work with global teams across Europe, North America, South America, Asia and Australia • Work alongside experts in clinical research, pharmacovigilance, and quality consulting