Description
Local Safety Officer - 6 months contract ParisOur client, global pharmaceutical company is looking for an experience pharmacovigilance consultant to take responsibility for ensure local PV system oversight, including any elements of the PV system that are contracted to a third party.
The position has the responsibility in France for ensuring AE reports and submissions to health authorities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners.
the LSO ensures that adverse event information received locally contributes to the company knowledge of the safety profile of its products.
The LSO is declared to ANSM as the local qualified person for PV in France and must reside and work in France in compliance with a. R of French Public Health Code.
Main tasks:
- Act as the local Qualified Person for Pharmacovigilance, in accordance with French regulations (article R. of French Public Health code);
- Develop and maintain effective business relationships with external parties in addition to tracking performance metrics including regulatory compliance;
- Follow-up adverse events as necessary, providing new and updated information to GDS Maintains local source documents in accordance with applicable record retention requirements;
- Act as primary contact for GDS in France and countries of responsibility;
- Executes CAPA plans relevant to the LSO role as necessary, and oversees the development, implementation and execution of any necessary CAPA plans by third parties that support the LSO's area of responsibility;
- Ensures local regulatory intelligence. Maintains and seeks out a thorough understanding of global and local requirements that relate to the LSO role, identifying and communicating emerging needs to introduce process changes to remain compliant;
- Provides PV expertise to the selection and qualification of any Patient Support Program organized within the countries of responsibility and oversees PV activities related to Patient Support Program
- Performs root cause analysis of deviations relevant to local PV processes;
Please contract Beata Klecz zon
Michael Bailey International is acting as an Employment Business in relation to this vacancy.