Director Global Safety Periodic Reports

**Date de parution**:19 déc. 2023**Ville**:Saclay**Pays/Région**:FR**Type de contrat**:CDI**N° offre**:4854Director Global Safety Periodic Reports
- The Global Safety Periodic Reports Director is mainly responsible for organizing and supervising the planning, writing and submission of periodic reports ; guarantying the activity's compliance with regard to current regulations ; ensuring efficient implementation of periodic reports activities through monitoring of key performance indicators ; supporting continuous development of the team**Missions & Activities**
- The Global Safety Periodic Reports Director is responsible for:
- Organizing, planning, drafting periodic vigilance reports activities (PSURS, PBRER, etc.) and periodic safety reports required for clinical trials (DSUR, 6 monthly reports) as well as any safety report under the responsibility of the unit (clinical overview, Ad-cov, others) in collaboration with the contributing operational teams outside the Global Safety.
- Monitoring the Service provider related to the periodic report’s activities.
- Organizing the submission of these periodic reports to the competent authorities, and of transmission to the subsidiaries and partners when required in compliance with regulatory deadlines, internal deadlines and those established in partnership agreements respectively.
- Guaranteeing the traceability of these submission and transmissions to Business Partners
- Participating in impact analysis of regulatory intelligence regarding her/his scope of activities.
- Ensuring the unit's participation in cross-functional working groups

As generic responsabilities, S/He will ensure:
- Creating and maintaining quality documents related to her/his scope of activities and she/he ensures that those quality documents are in line with the regulatory requirements.
- Periodically reporting on her department's activities to the direct line manager.
- Identifying potential risks in terms of organisation and needs. She/he proposes solutions and corrective and preventive actions when needed.
- Contributing to preparing and monitoring inspections and audits by business partners on a Global Safety departmental level and in the regions allocated to her/his unit.
- Development of the team she manages, including recruitment, annual appraisal, monitoring and recognising performance, and individual employee development (training and professional development).
- Drafting and managing the allocated budget.
- Developing his/her team, whilst embodying and promoting the Servier LeaderShip Model, in respect, compliance and alignment with HR internal rules and best practices

**Profile & Experience**
- Physician, Pharmacist
- At least 15 years of experience within the pharmaceutical industry in the PV field at the Corporate and in an international environment as well as in analysis of PV data.
- Excellent knowledge of regulatory requirements at the worldwide level
- 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.