Freelance / Consultant 1 FTE Local Safety Officer in France

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Freelance / Consultant 1 FTE Local Safety Officer in France, Paris

Client:

Location:

Paris, France

Job Category:

Consulting

-

EU work permit required:

Yes

Job Reference:

235897fbe31c

Job Views:

3

Posted:

25.04.2025

Expiry Date:

09.06.2025

Job Description:

This is an exciting opportunity for a freelancer / consultant to join our team as Local Safety Officer in France.

By working with us, you will have the opportunity to work in an international team and strengthen your expertise within the broad and diverse PV and Regulatory Affairs area.

Main responsibilities

• PV Cases Handling: Receipt of initial or follow-up AE cases including combination products, case registration, documentation in the local tracker, translation into English, transmission to IPV team, follow-up, archiving, case closure, quality control, and translation QC.
• Signal detection: Reception and review of global listings, causality assessment, validation, and analysis of signals.
• Monthly identification of non-conform use cases and transmission for analysis.
• PV Quality Management System review and comments.
• Inspections and audits support and preparation.
• Reconciliation tasks including compliance checks and CAPA for local studies and third parties.
• Provision of local regulatory intelligence and expert advice.
• Management of risk minimization measures related to safety restrictions and emerging issues.
• Local literature and regulatory website screening for ADRs and safety information.
• Training updates and face-to-face training for new employees.
• Preparation and presentation of PV data/KPI.
• Monthly coordination with CPO.
• Management of the generic PV mailbox.
• Stakeholder management and interface coordination.
• Involvement in local labelling safety changes, if applicable.

Qualifications

• Must reside in France.
• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent.
• Minimum 2-3 years of pharmacovigilance experience.
• PV training and/or relevant professional background.
• Expert knowledge of ICH GVP and local legislation.
• Proficiency in English and French, both written and verbal.
• Proficiency in MS Office applications.
• Must currently be set up to work as a freelancer / consultant.

Additional Information

We prioritize diversity, equity, and inclusion, creating an environment where all backgrounds can contribute and grow.

Our offer includes a dynamic team, multicultural environment, and a friendly workplace.

Our core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships.

We look forward to your application.