and engineers in Italy and abroad
VIGILANCE MANAGER 50%
ER Services islooking for a Vigilance Manager at 50%on behalf of an important client, a Swiss company based in Lugano, active in theproduction and marketing of medical devices and pharmaceutical products.
The candidate is able to take over the responsibilities ofEuropean Qualified Person for Pharmacovigilance (EU-QPPV) and manage allactivities related to the pharmaceutical and medical devices vigilance incompliance with all applicable regulations. Regulatory affairs support.
· To be responsible of all vigilance activitiesfor pharma and MD products;
· To coordinate with the company partners, anyinformation that could have an impact on the pharmacovigilance/medical devicevigilance activities including the management of the safety data exchangeagreements (SDEA);
· To monitor and follow-up of the PSURs or RMPsand the PVSMF and its summary with the current external PV subcontractors, withthe aim to integrate the externalized activities in the near future;
· To manage all Pharmacovigilance events relatedto the Company products in collaboration with the current external PVsubcontractor, with the aim to integrate the externalized activities in thenear future by evaluating, coding and declaring the events to the Authorities(management of all related database);
· To directly manage all the Medical devicevigilance activities;
· Management of primary notification form,individual serious incidents and risks of incidents, Field Safety CorrectiveActions (FSCA), explanatory statements, trend reports, periodic summary report,report on suspected serious incidents received from Health authorities, finalreports, Field Safety Notice;
· Monitoring of Pharmacovigilance and medicaldevice vigilance regulations, guidelines and literature;
· Writing and updating of the standard operatingprocedures related to Pharmacovigilance and medical device vigilanceactivities;
· To train the team for vigilance activities andbe part of vigilance audit;
· To support regulatory affairs activities.
· Degree in life sciences;
· At least 5 years’ experience inpharmacovigilance and medical device vigilance;
· EU resident to bear the EU QPPVresponsibility;
· English (fluent), French knowledge will beconsidered a plus;
· Good computer skills;
· Good knowledge of the pharmaceutical and medicaldevices vigilance regulations and guidance;
· Good communication skills;
· Rigorous and autonomous;
· Pro-active attitude and decision maker;
· Problem solving and attitude to work under tightschedule.
If interested, fill in the form below or send your CV viaemail to: email@example.com
|Years of experience required||3 to 5|
|Education required||university degree|
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