Director Global Safety B/r Evaluation
il y a 2 semaines
**Date de parution**:19 déc. 2023**Ville**:Saclay**Pays/Région**:FR**Type de contrat**:CDI**N° offre**:4851Director Global Safety B/R Evaluation
- We are looking for you as a Benefits & Risks Evaluation Director to join our Global Safety Head Dept- You are leading the management of Signal detection, Risk management system, the responses to questions from competent authorities, ensuring Safety communication and the management of studes's safety part, observing domestic and international regulatory requirements.
- You act as Deputy EEA QPPV.- You commit to contributing to the team continuous excellence.**Missions & Activities**
- The Director Global Safety B/R Evaluation is responsible for:
- Leading, strategizing, and maintaining a well-functioning and motivated Safety Benefit/Risk team spread accross France and US
- Providing strategic guidance for internal governance processes, cross-functional activities, and external contractual relationships for the Benefit/Risk evaluation unit on Servier portfolio
- Ensuring the signal detection process for Servier portfolio including detection, analysis, validation and communication and proposals for their subsequent action in terms of regulations.
- Overseeing and provides strategic guidance in the preparation of risk management plans activities including risk minimization measures for Servier portfolio.
- Overseeing a process for the contribution on the drafting and reviewing of all Reference Safety Information (Core Company Data Sheets, SmPC, RSI, Investigator Brochures).
- Coordoninating referral procedures addressed for safety reasons.
- Sécuring responses to questions from the competent authorities are correctly addressed in term of timelines and quality.
- Contributing and reviewing of studies protocols and all related documents (interventional, non-interventional and other programs).
- Implementing of safety communication process.
- Ensuring the contribution and review of the safety part of the MAA dossier.
- Coordinating action required by the team in the event of crisis management related to product risk management and safety.
- Ensuring the participation of the unit in scientific monitoring (bibliography, congress, contacts with experts...)
- Representing Benefit/Risk evaluation unit, when needed, at Benefit/Risk and Labelling Committee or other ad hoc meetings
- Providing oversight and support in the preparation and review of safety sections of clinical documents, including safety contributions to protocols, clinical study reports (CSRs), Reference Safety Information (RSI) sections of the Investigator’s Brochure (IB), ICFs, and other study-specific documentation as needed, by cross-functional procedures and in compliance with Health Authority requirements
- Participating in impact analysis of regulatory intelligence regarding her/his scope of activities.
- Acting as the deputy of the EEA QPPV.
**Profile & Experience**
- Physician
- At least 15 years of experience within the pharmaceutical industry in the PV field both in clinical and post-marketing settings and in analysis of PV data, especially for products covered by a risk management plan.
- Expert knowledge of PV processes and international regulatory requirements.
- Ability to represent the EEA QPPV during her absence
- Full proficient English
**Leadership skills and aptitudes**
- Proven conceptual thinking and strategic problem-solving ability.
- Ability to prioritize and lead various team members at various levels to achieve goals
- Serve as a role model, demonstrating respect and inclusion.
- Proven ability to adapt to change and manage cultural change in an evolving environment.
- Ability to speak forthrightly and encourage others to do the same.
- Ability to propose and make decisions that benefit the Global Safety in collaboration with the line management. Ability to foresee and identify issues and then propose and develop solutions in compliance with the legal requirements.- Quel que soit votre domaine d'expertise, votre travail au sein du Groupe Servier contribue à faire avancer le progrès thérapeutique au bénéfice des patients. Vous ferez partie d'équipes reconnues pour leur excellence scientifique et développerez votre plein potentiel dans un environnement professionnel qui vous encourage à vous développer. Des parcours d'intégration sur mesure, des opportunités de mobilité, des formations de qualité, un management responsable, un esprit d'équipe... Tout cela et plus encore dans un lieu de travail axé sur votre bien-être.- Chez Servier, nous sommes engagés dans le progrès thérapeutique au service des besoins des patients. Nous mettons la diversité de nos collaborateurs comme une source de richesse pour l'accomplissement de cette vocation.
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