Pharmacovigilance & Safety Manager (M/F)
Consultant Eloise Perot
Date de création 10 octobre 2018 2018-10-102018-12-09 pharmaceuticals 25 rue Balzac Paris 75008 Robert Walters France
The position is accountable for managing overall pharmacovigilance activities and ensuring that these activities are conducted in compliance with Global Regulatory requirements and corporate SOPs.
Our client is a dynamic biopharmaceutical company developing innovative drugs for metabolic diseases.
Based in Lyon, the Pharmacovigilance & Safety Manager reports to the Director, Clinical Development. You will responsible for:
• Regulatory safety
- Responsible for reporting of safety information during clinical trials in an international multi-partner context
- Responsible for preparing periodic safety updates (DSUR)
- Responsible for developing or providing support to internal safety document (RMP, CCSI, IB/RSI….)
- Responsible for developing or reviewing PV agreement with potential partners
• Clinical Trial Safety Monitoring
- Responsible for trial related safety activities: review of Safety Management Plan; review of safety listings on a regular basis for signal detection and safety monitoring; review of narrative for SAE or AE of specific interest
- Responsible for set up and overview of cross reporting activities within each drug development program
- Responsible for selecting and managing a safety provider for global safety database in new drug development
• Signal detection and management
- Responsible for setting up and leading preclinical and clinical meetings within team for early evaluation of the safety of compounds in order to anticipate potential safety signal
- Responsible for setting up and leading Data and Safety Monitoring Board or safety Committee as appropriate during the development of a compound
• Compliance and Quality
- Responsible for developing or supporting the development of SOPs related to safety activities within company
- Responsible for ensuring the compliance with good clinical and regulatory practice in all safety activities
MD or PharmD, you should have 5 to 10 years of pharmacovigilance experience in pharmaceutical companies. A previous experience in Clinical Development is preferred and a first experience in a biotech structure will be a strong asset. A strong knowledge in Pharmacovigilance Safety Management File (PVSMF) and the ability to manage CROs are required for this position. Furthermore, you should have a knowledge of relevant international regulations/guidelines and strong understanding and usage of medical terminology. French and English are mandatory.
You are independent, pro-active, self-motivated and passionate about Clinical Operations. With an entrepreneurial spirit, you will be capable of working in a start-up environment.