Pharmacovigilance Case Processing Manager F - m H/F Servier

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

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