Director Global Safety Case Processing - Saclay, France - Servier

Servier

Entreprise vérifiée

Saclay, France

il y a 1 semaine

Posté par:

Sophie Dupont

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Description

Date de parution:29 janv

2024
Ville:

Saclay
Pays/Région:
FR
Type de contrat:CDI
N° offre:4855Director Global Safety Case Processing & Tools management

We are looking for you as a Case Processing & Tools management Director to join our Global Safety
You will ensure that robust processes are in place for the management of case processing activities and IT tools maintenance, coordinating the development of our systems in order to allow continuous improvement of the department's activities, managing these projects with your team, in line with the Group & Department' strategy and objectives, and securing GS business continuity.
You commit to contributing to the team continuous excellence.
Missions & Activities
The Global Safety Case Processing & Tools management Director is responsible for:
Ensuring the setting of a robust case management process.
Monitoring daily the management of pre and postmarketing vigilance cases (all regulatory statuses) in line with the Case Management team and the Service provider: bookin, data entry, documentation, evaluation, quality control medical review and submission of the cases to ensure compliance with regulatory requirements, with Safety Data Exchange Agreements and procedures in place.
Selecting and managing the service providers: draft of the specifications, selection of the service provider (in line with the rules applicable within the Group (purchasing and legal aspects)), draft of the service contract, monitor the quality of the service.
Setting up and monitoring the activities outsourced to the service providers.
Ensuring the implementation and followup of the literature surveillance process as well as the monitoring of the service provider in charge of this activity.
Participating in impact analysis of regulatory intelligence regarding her/his scope of activities.

As for IT Tools management and Project Management, S/He is responsible for:

Setting up IS (Information Systems) in order to support activities handled by GS and guarantee the compliance of these activities.
Ensuring a proper configuration and maintenance of the systems in line with business and regulatory requirements.

Manage and guarantee the conformity of the validation activities of each of these ISs:

establishing the validation strategy and plan in liaison with the QA department; ensuring their maintenance (including change and incident management).

Providing key performance indicators regarding PV activities.
Organizing the projects of IS upgrades in line with the strategy defined by the Global Safety.
Piloting and supervises all steps of an IS project for GS systems: definition of business and regulatory needs, choice of editors of the solution and potential integrators, monitoring of project deliverables, ensuring respect of deadlines and project costs. Set up business project teams ensuring the running of projects.

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

Pharmacist, Scientific or informatic degree
At least 10 years of experience within the pharmaceutical industry in a PV international environment, with activities related to vigilance cases' capture.
Experience in managing information systems dedicated to PV and in IT project management
Excellent knowledge of regulatory requirements at the worldwide level
Full proficient English

Leadership skills and aptitudes

Proven conceptual thinking and strategic problemsolving 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 w