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

🔥 9 minutes ago

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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 across assigned projects and teams and oversee workflow • Support effective cooperation with clients in ICSR Management • Contribute to company goals and objectives under the supervision of the ICSR Operational Lead • Support other project team activities on behalf of the client and company • Create and maintain project-specific KPIs for contracted ICSR activities • Optimize procedures, trainings, and other actions to increase 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-level quality control of cases • Support other departments as instructed • Operate as the assigned team subject matter expert • Support the RA & PV Network Department, including acting as LCPPV for the specified country and PRLS for the designated language

🎯 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, attention to detail, and multitasking ability • Delegation skills • Planning and time management skills • Technical skills • Team working skills • Fluent spoken and written English • Advanced literacy in MS Office

🏖️ Benefits

• Remote work option • Collaborative team environment • Flexible work culture • Growth opportunities • Supportive workplace culture • Opportunity to work on global projects • Opportunity to contribute to patient safety • Work with experts in clinical research, pharmacovigilance, and quality consulting