Pharmacovigilance Case Processing Manager F

il y a 3 semaines

Saclay, France Servier Temps plein

Missions & Activities

Within Global Safety Department, the PV Case Processing Manager reports to Case Management and Pharmacovigilance Systems Dir., leads a dedicated team and achieves the following

Case management

- Setting a robust case management process.
- Monitoring daily the management of pre- and post-marketing vigilance cases (all regulatory statuses) in line with the Case Management team and the Service provider (book-in, 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 service providers (draft of specifications, selection of the provider in line with legal and purchasing internal rules, draft of the service contract, quality of service monitoring)
- Setting up and monitoring the activities outsourced to the service providers.
- Ensuring the implementation and follow-up 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.
- Setting-up of the SMP (safety management plan) prior study initiation
- Contribution on the monitoring of Key performance indicators

General responsibilities

- 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/his department's activities to the direct line manager.
- Identifying potential risks in terms of organization and needs. She/he proposes solutions and corrective and preventive actions when needed.
- Contributing to the preparation 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/he manages, including recruitment, annual appraisal, monitoring and recognizing performance, and individual employee development (training and professional development).
- Ensuring the follow-up of 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
- At least 6 years of experience within the pharmaceutical industry in the PV field in an international environment in particularly in activities to capture vigilance cases.
- Knowledge of information systems dedicated to PV and in IT project management
- Excellent knowledge of regulatory requirements at the worldwide level
- Fluency in English.
- Leadership skills & aptitudes

Nous sommes engagés pour l'égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l'expérience qu'à l'envie de s'engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.

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