About the job:
Our Team:
An interesting role has become vacant at Sanofi’s Barcelona Office. As Country Safety Manager, you collaborate with the CSH in the maintenance of a pharmacovigilance system that ensures the registration of all safety information and the design, implementation, management and control of a risk-benefit safety strategy that meets the requirements established by Integral Pharmacovigilance [GPV] and the Spanish Agency of Medicine and/or other official bodies regarding the assigned products that are authorized/marketed or in the investigation phase.
Main responsibilities:
Management of operational activities
To carry out the oversight of the outsourced activities
- To ensure the qualitative and quantitative compliance of the Pharmacovigilance (PV) activities, in accordance with the legislation in force, according to the procedures of GPV and of the Spanish Agency of the Medicine and other official bodies
- Manage or assist in compliance and quality control activities
- Analyze and contribute to the annually planning of the Periodic Safety Reports (IPS)
- Planning and development/updating of Pharmacovigilance licenses and agreements (SDEA) for existing licenses
PV Quality System Management
- Ensure that processes to comply with local PV regulations and Sanofi Group's global procedures are implemented, documented and followed locally
- Preparation and implementation of safety training for company staff and personnel acting on behalf of the company
- Participate in audits as required and in the development of corrective and preventive actions, as necessary
- Development and maintenance of the local PV System Master File in accordance with the global standards
Medical and scientific safety management activities for assigned products
- Handling of responses to requests from health authorities in collaboration with GPV
- Awareness of emerging changes in the safety profiles of products is maintained
- Support the CSH in the sent
📌 Country Safety Manager (Barcelona)
🏢 Sanofi
📍 Barcelona
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