Safety Systems Specialist - pharmacovigilance

Safety Systems Specialist - pharmacovigilance

Safety Systems Specialist - pharmacovigilance

Safety Systems Specialist - pharmacovigilance

SIGMA7 GmbH

Internet, IT

Neuenburg

  • Art der Anstellung: Vollzeit
  • 72.500 CHF – 104.000 CHF (von XING geschätzt)
  • Vor Ort

Safety Systems Specialist - pharmacovigilance

Über diesen Job

Do you want to join Philip Morris? We're looking for a :
At PMI, we embrace innovation. We utilize an automated safety database hosted on a multitenant platform, which necessitates a shift in typical system maintenance while adhering to GxP guidelines. Continuous system releases provide ample opportunities for further improvements in our system usage.
We seek a candidate who can connect system performance data with business requirements, someone inquisitive, solution-oriented, and innovative.
Your role will be to manage the assigned safety systems maintenance activities including but not limited to:
  • IT support liaison: ensure all incidents are appropriately addressed by the IT support and escalated if needed
  • ISQA liaison: ensure system inspection readiness at all-times by following GxP quality principles, be the safety systems Subject Matter Expert for audit/inspection.
  • Case management liaison: together with the Case Management team detect and implement technical solutions to facilitate automated case processing

In your role, you will have the ability to support our safety operational excellence and contribute to our pioneering work on automated safety systems.
  • Oversee the IT support team to ensure timely and effective resolution of incidents
  • Establish and follow incident escalation processes
  • Manage new system releases / patch fixes implementations
  • Define the business requirements with the Case Management team and implement them in the Safety Database following the Change management process
  • Detect system performance issues and support solution implementation
  • Create templates for aggregate reports (e.g. Signal Detection) and generate them on an adhoc basis
  • Implement new systems or technical solutions in the Safety Systems landscape in collaboration with IT, Validation team and other stakeholders
Author and maintain guidelines and instruction documents, support QMS maintenance
  • Graduated with a BSc or MSc in life sciences or IT.
  • 3 5 years of experience in the Safety Systems maintenance (like LSMV, Argus or similar)
  • Experience with change management and validation processes.
  • Flare for new technologies and IT systems with good investigational skills.
  • Strong verbal and written communication and documentation skills required, with high attention to detail.
  • Willing to learn and able to work independently in a dynamic corporate organization, under pressure of tight deadlines.
  • Ability to prioritize the workload with strong time management skills.
  • Express technical concepts in a nontechnical manner
  • UE27/AELE nationality or a valid Swiss Work Permit required for this position due to legal compliance in Switzerland.

Gehalts-Prognose

Unternehmens-Details

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SIGMA7 GmbH

Internet, IT

Bern, Schweiz

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