Area Safety Officer

Area Safety Officer

Job Title: Area Safety Officer

Work Location: Issy-les-Moulineaux (2 days at office)

Country: France

Duration: 12 months

Salary: €50,000 per year

Your Main Duties as an Area Safety Officer Will Include:

1. Performing the quality check of the PV cases and ensuring that the English translation has been properly performed.
2. Keeping up to date a local tracker of the individual safety reports, as well as acting as the subject matter expert at local level on the case management activities.
3. Adhering to regulatory timelines of the submission of the safety reports to the local health authorities and communicating any potential delay to the appropriate teams.

Additional Duties Will Include:

1. Establishing and maintaining local indicators on the compliance of the safety reports submission.
2. Supporting in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaboration with the global team to develop and implement CAPA plans as applicable.
3. Providing PV clauses to be included within local agreements and contributing to the PSMF with contracts-related information.
4. Ensuring implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

Your Background:

• Healthcare science professional or equivalent training.
• Significant training in case data management with strong IT skills.
• 2-4 years of relevant experience (e.g., case data management, reconciliation manager, vigilance IT project manager).
• Language requirements: English and French (verbal and written) at professional working level.