Senior Pharmacovigilance Officer, Team Lead – Medical Device Experience

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ERGOMED

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 1997

💼 Beratung

🏥 Gesundheitswesen

📦 Logistik

Consulting • Healthcare • Logistics

ERGOMED ist eine weltweit tätige Unternehmensgruppe, die spezialisierte Dienstleistungen für die Biotechnologie- und Pharmaindustrie erbringt. Sie ist in verschiedenen Geschäftsbereichen aktiv, darunter Ergomed Clinical Research, PrimeVigilance und ADAMAS Consulting, und bietet als Clinical Research Organization (CRO) umfassende Full-Service-Fähigkeiten. Mit Fokus auf Onkologie, seltene Erkrankungen und komplexe Studien bietet Ergomed zudem End-to-End-Pharmakovigilanz- und Medical-Information-Services sowie umfassende GxP-Audits. Ergomed unterstützt die Arzneimittelentwicklung mit einer globalen Präsenz in rund 100 Ländern.

Beschreibung

• 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 of 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 • Providing 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 (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 • Support other departments, as approved and instructed by ICSR Operational Lead • Operates as the assigned team SME • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

🎯 Anforderungen

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • Strong previous work experience in pharmacovigilance within which 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)

🏖️ Vorteile

• 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