Area/Local Safety Officer Consultant

Job Description

ClinChoice is seeking an Area/Local Safety Officer Consultant for a 12-month contract, potentially extendable, to work with one of its clients. This role requires a minimum of 2 days per week in the office located in Issy-les-Moulineaux, France, with the flexibility to work remotely for the remaining days.The Area Safety Officer will ensure that local operating company (LOC) safety activities related to all products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels. They will also adhere to product vigilance agreements with third-party business partners.Responsibilities:

• Perform quality checks of PV cases and ensure proper English translation.
• Maintain a local tracker of individual safety reports.
• Serve as the subject matter expert on case management activities at the local level.
• Monitor regulatory timelines for safety report submissions to local health authorities.
• Establish and maintain local indicators on safety report submission compliance.
• Oversee training for local employees and business partners.
• Maintain and present KPIs during team meetings.
• Perform regulatory monitoring for impact on vigilance activities.
• Conduct reconciliation with other departments and stakeholders.
• Maintain oversight of local literature articles for AE reporting.
• Perform reporting/submissions of safety reports to local health authorities.
• Support the Area Safety Lead in notifying local health authorities of safety issues.
• Maintain up-to-date knowledge of local pharmacovigilance requirements.
• Record self-identified non-conformances and collaborate on CAPAs.
• Perform document management and archiving as required.

Requirements:

• Health care science professional or equivalent training.
• Significant training in data management with strong IT skills.
• 2-4 years of relevant experience in case data management or vigilance.
• Fluent in English and French (mother tongue).
• Excellent communication skills and ability to work with cross-functional teams.
• Rigor and attention to detail.

ClinChoice offers:

• Opportunity to work directly for a single sponsor while having the security of a global CRO.
• Professional development and a supportive culture.