EMEA Vigilance Manager F/H

Hiring By - Biostaffic

 BioPharma

France

Job Highlights

Not Disclosed

Posted 4 months ago
Job details

Job description :


  • Implementing local vigilance and quality systems in the region.
  • Drafting procedures, instructions, forms, based on the global QMS and the local/ regional regulations.
  • Providing indicators of conformity and compliance to regulations and processes.
  • Preparing the local PV teams to audits and inspections (developing tools, documentation, digests of the main PV inspection findings…).
  • Implementing CAPA plans following audits and inspections.
  • Coordinating the communication between the vigilance team at headquarters and the local PV teams.
  • Setting up regular meetings with the partners to review the main vigilance topics, explaining some global processes and supporting them in their queries.
  • Performing the regulatory intelligence in the region, summarizing it and sharing it with the teams.
  • Ensuring that the vigilance agreements are executed.


Education / Background required :


- Scientific background

- 4-6 years of experience in the corporate vigilance department of a pharmaceutical company.

- Previous experience in the interaction with company business partners is required.

- Written and spoken English is mandatory.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • France

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
Company Overview
Excelya
Excelya

Current Openings: 0

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by compassion, care, and excellence.  Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
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