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Pharmacovigilance Officer

Offerta: Pharmacovigilance Officer

Soggetto:Pharmacovigilance Officer
Luogo: Bioggio
Azienda: Ginsana SA
Data: 2019-03-06

Dettagli dell'annuncio di lavoro Pharmacovigilance Officer

Descrizione: Responsible for setting up and maintaining a Pharmacovigilance system for SFI products. • Responsible for the creation and implementation of SOPs for Pharmacovigilance system and for the internal Pharmacovigilance Working Instructions, • Responsible for co-ordinating with the PV Consultant/CRO and updating the Client SOPs. • Responsible for ensuring the proper processing of Adverse Event (AE) case reports for SFI products and for all communication concerning drug safety matters between SFI and Contract Research Organisations (supplying the support to the PV System and the safety database) and the Business partners (e.g. sales agents, distributors). • Ensures quality of data according to company standards and compliance with the Regulatory reporting timelines. • Ensures the distribution of Serious Adverse Events to Business partners for information and eventual reporting. • Proposes a schedule for audits of Business partners and identifies those which are considered “high

Luogo di lavoro: Bioggio via Mulini, 6934 Bioggio