HEAD OF PV/MI -EU QPPV- Pharmacien Responsable Intérimaire section B - LABORATOIRES DELBERT - PARIS, France
(2025-03)
- Sustaining a compliant Global PV system and overseeing EU QPPV activities.
- Updating and maintaining the Pharmacovigilance System Master File (PSMF).
- Developing and analysing PV metrics and KPIs (e.g., ICSR reporting, PBRER submissions).
- Coordinating cross-functional interfaces (Legal, Business, Marketing, Regulatory Affairs) to develop and manage Safety Data Exchange Agreements (SDEA).
- Monitoring and implementing international regulatory changes to ensure compliance with evolving PV guidelines.
- Leading audit and inspection readiness, encompassing preparation, execution, response management, and documentation maintenance.
- Designing and delivering appropriate PV training for both internal and external stakeholders.
- Guiding the project for global PV vendor selection.
- Facilitating product and company acquisitions from a PV perspective (e.g., database transfer, PV Agreement).
- Establishing a robust signal detection process.
- Preparing, validating, and submitting PV reports (PSUR, PBRER, RMP).
- Conducting medical reviews of Adverse Drug Reactions (ADRs).
- Ensuring PV quality assurance.
GLOBAL SAFETY & MI MANAGER -EUQPPV DEPUTY -Pharmacien Responsable Intérimaire section B - LABORATOIRES DELBERT - paris
(2022-06 - 2025-02)
- Supporting QPPV activities and acting as a backup to ensure continuity of the Pharmacovigilance system during absences.
- Managing the pharmacovigilance and risk management systems.
- Overseeing PV case management (intake, data entry, QC, and medical validation).
- Processing and submitting adverse event reports and updated safety communications.
- Functioning as the local QPPV in France for three marketing authorisation holders.
- Updating safety information and reporting any new risks or alterations in existing risks, or changes in the observed benefit/risk ratio to the ANSM and EMA.
- Managing PV providers and partners (PV agreement).
- Ensuring PV quality assurance.
- Overseeing MI activities, including responding to healthcare professionals and patients, and establishing an FAQ section.
PHARMACOVIGILANCE & QUALITY MANAGER - LABORATOIRES DELBERT - Paris
(2018-06 - 2022-05)
- Ensuring compliance with good distribution and management practices (GDP) through the implementation of appropriate procedures and controls.
- Contributing actively to quality-related projects to optimise processes, enhance compliance, and drive continuous improvement.
- Overseeing internal quality-related activities, including document management, resolution of non-compliance issues, complaints, CAPA, training, change control, batch tracking, and key performance indicators.
MEDICAL INFORMATION OFFICER - PATIENTY'S - boulogne billancourt
(2018-04 - 2018-06)
- Monitoring regulatory and scientific developments to ensure compliance with current requirements.
- Managing medical and scientific inquiries from healthcare professionals, patients, distributors, and international partners, providing accurate and compliant responses.
- Analysing scientific data to supply accurate responses tailored to the needs of international partners.
