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

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ERGOMED

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1997

💼 Conseil

🏥 Santé

📦 Logistique

Consulting • Healthcare • Logistics

ERGOMED est un groupe international qui fournit des services spécialisés aux industries biotechnologique et pharmaceutique. Il opère à travers plusieurs lignes de services, notamment Ergomed Clinical Research, PrimeVigilance et ADAMAS Consulting, et se consacre à offrir des capacités complètes de CRO (Contract Research Organization). Axé sur l’oncologie, les maladies rares et les essais complexes, il propose également des services de pharmacovigilance et d’information médicale de bout en bout, ainsi que des audits GxP complets. Ergomed s’engage à accompagner le développement de médicaments, avec une présence mondiale dans une centaine de pays environ.

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 processes • Support 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 instructed • Operate as the assigned team subject matter expert • Support the RA & PV Network Department, including acting as LCPPV for a specified country and PRLS for a designated language

🎯 Exigences

• 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

🏖️ Avantages

• Remote work • Flexible working environment • Growth opportunities • Supportive and collaborative team culture • Opportunity to work with global teams • Passionate team of experts in clinical research, pharmacovigilance, and quality consulting