Freelancer profile translated to English.

Description

With extensive experience in setting up and improving a pharmacovigilance system, I help companies achieve a high level of compliance, efficiency, and operational control. I can also act as Head of Safety, EU QPPV, and local QP for France or Switzerland. I can also step in to cover your PV staff in case of absence (maternity leave, sick leave) or during periods of increased workload. My service is based on the following values:

Patient safety first. All my work is centered on this fundamental value.
Contribution to the smooth running of the company. Pharmacovigilance should not be a barrier to the company's development.
Regulatory compliance. This is the foundation of all pharmacovigilance activities.
People at the center of my concerns, especially as a Manager.
Customer service and excellence in my work are core values.

Languages

English
Native or bilingual
French
Native or bilingual

Workplace preferences

Can work on-site

Genève (up to 50km)

SUBSTIPHARM BIOLOGICS SA
Consultant in Pharmacovigilance
PHARMACEUTICALS INDUSTRY
March 2026 - April 2026 (1 month)
Plan-les-Ouates, GE, Switzerland
Objective: analysis of the pharmacovigilance system and preparation for a partner audit
• Gap analysis
• Remediation plan
• Writing or adapting procedures
• Various advice on improving and ensuring compliance of the pharmacovigilance system
Key results: finalization of the gap analysis and remediation plan, proposal of 14 new procedures or procedure improvements
Project management Gap analysis Remediation plan Procedure writing Organizational consulting
SANTHERA PHARMACEUTICALS
Drug Safety Manager - Contractor
PHARMACEUTICALS INDUSTRY
June 2024 - December 2025 (1 year and 6 months)
Pratteln, BL, Switzerland
Objective: ensure the continuity of the Pharmacovigilance system, then support geographical expansion and quality
• Writing of signal detection reports, writing of PSURs / PBRERs
• Management of clinical documentation, participation in clinical teams, reconciliation of SAEs
• Supervision of case management activities, service providers, and the PSMF
• Management of deviations / CAPA and participation in audits
Key results: improvement of the pharmacovigilance contract management process; closure of CAPAs, Revision of the format of monthly/quarterly signal detection reports
Pharmacovigilance Writing Clinical studies Deviation management Contract management
Teoxane SA
Head of Materiovigilance Department
PHARMACEUTICALS INDUSTRY
August 2023 - May 2024 (9 months)
Genève, Switzerland
Objective: structure and secure vigilance activities for class III implantable medical devices
• Management of a dedicated team (11 people)
• Supervision of case management and PMS activities
• Implementation of quality requirements according to MDR 745/2017 standard
• Cross-functional collaboration on patient safety (clinical development, quality, regulatory affairs)
Key results: implementation of a signal detection process adapted to medical devices, Revision of the health risk assessment process, organization of an operational Vigilance Committee
Team management Organizational consulting Materiovigilance Signal detection Database management