Beschreibung
Für einen Kunden in Frankfurt suchen wir derzeit einen Safety Data Manager (m/w/d) für eine Laufzeit von 1-2 Jahren. Das Projekt kann sowohl freiberuflich als auch in Arbeitnehmerüberlassung besetzt werden. Start wäre voraussichtlich Anfang Juni. Alle Aufgaben müssen auf Englisch durchgeführt werden.Ihre Aufgaben:
- Support maintenance of system configurations and data in the safety system in accordance with the company's methodology
- Support safety system user community by managing user requests throughout their full life-cycle
- Manage case deactivation process
- Ensure timely and appropriate escalation of risk
- Support, design, develop and test of Argus and E2B configurations
- Ensure maintenance of the validated state of the safety system
- Gather business user requests for safety system changes
- Provide subject matter expertise for safety system upgrades
- Assist in responding to regulatory authority queries
Ihr Profil:
- Minimum 4 years of supporting Pharmacovigilance/Drug Safety experience or equivalent required with subject matter expertise in software-based drug safety systems, direct experience with Argus required
- Detailed knowledge of Argus Safety Web configuration
- At least 2-5 years of experience and detailed knowledge of ICH E2B (R2) requirements, Argus E2B and gateway configuration
- Both pre-approval and post-marketing safety experience in a global environment highly desired
- Knowledge of relevant FDA, EU, PMDA, Health Canada and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
- Knowledge of MedDRA and WHO-DD coding dictionary