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Pharmacovigilance Manager–English speaking role i

Posted in: Jobs: Other in Switzerland
Last updated: 04/11/09

Pharmacovigilance Manager – English speaking role in Switzerland

An excellent opportunity has arisen within an exciting Biopharmaceutical company based in Switzerland. The company itself is one of the largest developers of vaccines in the world and is currently looking to recruit a Pharmacovigilance Manager. Within the position you will have no direct reports and instead will enable you to develop excellent hands on experience within a company dedicated to develop, produce and market products that combat infectious diseases.

As Pharmacovigilance Manager, you will be responsible for:

• Collecting, registering, handling, analysing for seriousness and expectedness, processing, narrative writing, and filing of AEs of the marketed products and the SAEs of IMPs
• Data entry using the safety database ArisG
• Preparation of the correspondence, managing follow-up procedures of ADRs
• ICSR Authority Reporting
• Performing monthly ICSR metrics and regular quality checks of the ADR files
• Reconciliation of the Authority databases (e.g. Italy, MHRA, CH, VAERS)
• Contribution to the maintenance of the regulatory reporting responsibilities
• Managing pharmacovigilance related literature and literature database
• Providing support in PSUR and RMP preparation

Successful applicants will have previous experience within Drug Safety. Knowledge of German will be a benefit but not essential.

For a confidential discussion and to find out more information about this interesting and diverse role, please contact Harriet Maidman

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