EMEA Vigilance Manager F/H

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.