| Description |
ER Services is looking for a Vigilance Manager at 50% on behalf of an important client, a Swiss
company based in Lugano, active in the production and marketing of medical devices and
pharmaceutical products.
The candidate is able to take over the responsibilities of European Qualified Person for
Pharmacovigilance (EU-QPPV) and manage all activities related to the pharmaceutical and medical
devices vigilance in compliance with all applicable regulations. Regulatory affairs support.
Responsibilities
? To be responsible of all vigilance activities for pharma and MD products;
? To coordinate with the company partners, any information that could have an impact on the
pharmacovigilance/medical device vigilance activities including the management of the safety data
exchange agreements (SDEA);
? To monitor and follow-up of the PSURs or RMPs and the PVSMF and its summary with the
current external PV subcontractors, with the aim to integrate the externalized activities in the near
future;
? To manage all Pharmacovigilance events related to the Company products in collaboration with
the current external PV subcontractor, with the aim to integrate the externalized activities in the
near future by evaluating, coding and declaring the events to the Authorities (management of all
related database);
? To directly manage all the Medical device vigilance activities;
? Management of primary notification form, individual serious incidents and risks of incidents,
Field Safety Corrective Actions (FSCA), explanatory statements, trend reports, periodic summary
report, report on suspected serious incidents received from Health authorities, final reports, Field
Safety Notice.
? Monitoring of Pharmacovigilance and medical device vigilance regulations, guidelines and
literature;
? Writing and updating of the standard operating procedures related to Pharmacovigilance and
medical device vigilance activities;
? To train the team for vigilance activities and be part of vigilance audit;
? To support regulatory affairs activities.
Requirements
? Degree in life sciences;
? At least 5 years? experience in pharmacovigilance and medical device vigilance;
? EU resident to bear the EU QPPV responsibility;
? English (fluent), French knowledge will be considered a plus;
? Good computer skills;
? Good knowledge of the pharmaceutical and medical devices vigilance regulations and
guidance;
? Good communication skills;
? Rigorous and autonomous;
? Pro-active attitude and decision maker;
? Problem solving and attitude to work under tight schedule. |
