Drug Safety Compliance Manager/International Deputy QPPV - Zurich

 — Opfikon
15.05.Employee100%

Drug Safety Compliance Manager/International Deputy QPPV - Zurich

We are currently looking for a Drug Safety Compliance Manager/ International Deputy Qualified Person for Pharmacovigilance (QPPV) to join our Global Drug Safety and Risk Management Team in Switzerland . In this leadership role you will be reporting directly to the International -/EU QPPV. You will be the liaison for our International-, Regional-, local QPPVs and Marketing Authorisation Holder representatives and help them maintaining the oversight of the Vifor Pharma PV system in their territory. Hence ensuring that Vifor Pharma maintains its license to operate through compliance with all rules and regulations for the products marketed. In addition you will be responsible to ensure that Vifor Pharma Group has a robust compliance tracking, monitoring, evaluation and escalation process with respect to the PV system and its PV related Quality Management System. For this you will provide (senior) management and stakeholders with compliance oversight thus ensuring patient safety and inspection readiness.

Your tasks and responsibilities will include, but not be limited to, the following:

  • Continuous global Regulatory Intelligence screening, impact assessment and control over Regulatory Intelligence information flow worldwide
  • Implement and maintain global PSMF and provision of PSMF-like documents 
  • Further efficiency improvement of compliance processes (automation, IT tools, electronic data access system, metrics generation and Key Performance Indicator monitoring)
  • Efficiency improvement of and coordination of procedural documents
  • Support/ advise/participate in the context of PV audits and inspections
  • Coordinate and provide training in area of expertise as a trainer on an as-needed basis
  • Support set-up PV system for new affiliates 
  • Ensuring appropriate PV related deviation and CAPA management

The ideal candidate holds a university degree in Biology, Biosciences, Pharmaceutics or a Medical Doctor in addition to the following experience: 

  • In-depth, demonstrated experience in most areas pertaining to PV, and PV Legislation
  • At least 5 years of work experience in PV functions
  • Demonstrated ability to accurately and effectively evaluate, interpret and present drug safety data and processes
  • IT affinity and advanced knowledge and expertise MS Office (Excel, Access and PowerPoint), and/or other IT systems
  • Understanding of medical aspects in therapeutic areas relevant for Vifor Pharma, along with willingness to develop in-depth expertise
  • Professional level in English, both in oral and written communications

You bring very good scientific, pharmaceutical and medical knowledge. You have excellent verbal and written communication skills. You are able to build and maintain good relationships with a strong customer focus and work effectively across cross-functional teams. You have excellent organisational, time management and project management skills and can think and influence conceptually, strategically and rationally. You take a thorough approach, with high attention to detail. You are able to interpret and apply global drug safety regulations and demonstrate a proactive attitude.

Kira Maurer
International Talent Acquisition Specialist
+41 58 851 83 48

Info

Info

15.05.2020
Employee, 100%
Contact
Kira Maurer
International Talent Acquisition Specialist
+41 58 851 83 48

Company

Size:1850 employees
Industry:Chemicals/Pharmaceuticals
Job offers:48 jobs
Location:Flughofstrasse 61
8152 Glattbrugg
Website:http://www.viforpharma.com
Salary

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