POS 3016
Status 5

Pharmacovigilance System Master File (PSMF) Manager

Beschreibung: For one of our Pharma clients in the greater Frankfurt area we are seeking freelance support as: Pharmacovigilance System Master File (PSMF) Manager (M/F/D)
  • Maintaining the oversight over the structures and performance of the pharmacovigilance (PV) system
  • Development and maintenance of the global PSMF
  • Authoring the global Biopharma PSMF
  • Ensure “up to date” and accurate content
  • Writing the body text and annexes
  • Consolidate PSMF data from contributors for body text and annexes
  • Ensure review, documented QC, approval, and publishing of the PSMF according to Biopharma’s procedures
  • Keep abreast of changes to the EEA regulations for PSMF and ensure that Biopharma’s PSMF stay compliant with these
  • Develop, Maintain and improve the processes and procedures related to - and the management of - the PSMF, e.g. review of the update cycles of annexes
  • Efficiently lead and drive the regular and ad hoc updates of global Biopharma’s PSMF and ensuring timely updates by the end of each quarter and annexes updates on a bi-monthly regular basis
  • Guide and influence cross-functional contributors inside and outside GPS to provide timely and high-quality data
  • Ensure that any requests for Biopharma PSMF from Health Authorities and auditors are met to the expected quality and in a timely manner
  • Hands-on experience in writing and maintaining a PSMF
  • Experience in Electronic Data Management Systems (e.g. CARA)
  • Profound Pharmacovigilance knowledge (clinical trials, post-marketing)
  • Experineced in Quality Management
  • Must Have: Business fluency in English
Bemerkungen: WANTED: Pharmacovigilance System Master File (PSMF) Manager (M/F/D). Please contact +49 89 18 90 998 44 or Skills: Drug Safety / Pharmacovigilance, English, Pharma
Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 5 Months +
Einsatzort: Greater Area Frankfurt
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

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