Medical Writer - Outsourcing Coordinator

Lieu: Switzerland - Glattbrugg/Zurich

Votre profil

In this exciting position we are seeking a motivated, creative, and innovative Medical Writer & Outsourcing Coordinator to join our dynamic team in Zurich or Geneva. In this role you will be reporting to the Head Global Drug Safety Centre of Excellence and Medical Writing department. 

Your responsibilities and Tasks will include, but not be limited to:
  • Timely handling of aggregate safety reports to Regulatory Affairs for compliant submissions 
  • High quality production of periodic and cumulative safety reports for the different CSL Vifor products in compliance with ICH, FDA and EMA guidelines
  • Drafting of aggregate safety information from different sources (spontaneous, clinical trial, literature, and others)
  • Providing support to Regulatory Affairs in the understanding of local requirements and advising of commercial strategies
  • Effective and timely implementation of CAPA as result of Audits and Inspection
  • Maintenance of updated SOPs as per new regulations and change in processes
  • Operational management and governance of outsourcing partners measured by Key Point Indicators 
  • Assist CRO management for the conduct of outsourced aggregate reporting, signal detection and literature review activities
  • Operational support to outsourcing partners via weekly meetings and ongoing communication
  • Governance support through contract management (Notice of Commission)
  • Invoicing oversight and regular operational and governance meetings as required
  • Additional duties on assignment
What we require from you:

Minimum Requirements
  • University degree in pharmacology / medicine / other life sciences
  • Minimum of 2 years of working experience in post marketing surveillance / drug safety operations including: case classification, causality, labelling, MedDRA, WHO-Drug coding and narratives
  • Good understanding of aggregate reporting; benefit-risk assessment; signal detection and risk management
  • Fluency in English
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
Preferred Requirements
  • Experience with drug safety databases (especially ARISg)
  • Experience in PV Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management
  • People and Project management training / experience
  • Experience with MS SharePoint and Visio
If you are interested and you are a strong team player, proactive, flexible with very good communication skills, processes & compliance as well as a strong commitment to quality and accuracy then we would very much like to hear from you.

A propos de nous

Afficher/masquer le contenu

Postuler
Partager

Conditions pour les agences de placement