Safety Data Manager (m/w/d)

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