Job offers for technical profiles
and engineers in Italy and abroad
cerca lavoro

cerca lavoro



accedi all'area aziende

tutorial candidati
Tutorial italianotutorial lavoro
English tutorialtutorial lavoro

 

 

 

 

 

 

 

 

 

 

 

Offer description
Title:

VIGILANCE MANAGER AT 50%

annuncio lavoro
Sector Science (Other)
Category Biomedical Engineer.
lavoro tecnico
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.

lavoro meccanico
Nation Switzerland
Region NO ITALY
Province NO ITALY
Location Lugano
lavoro elettrico
Years of experience required 3 to 5
Education required university degree
candidati all'annuncio di lavoro
lavoro specializzato

Condividi profili tecnici
| | |
Job opportunities that may be of interest to you:

To see job offers details press the title.

  Date Job offer title Location Sector  
  07/04/2021 VIGILANCE MANAGER 50% Switzerland Science (Other)  
  18/03/2021 BUSINESS DEVELOPMENT MANAGER Switzerland Science (Other)  
  27/01/2021 ANALISTA DI LABORATORIO CHIMICO Switzerland Science (Other)  
  08/04/2021 DIPLOMATO PERITO CHIMICO MANTOVA Science (Other)  
  07/04/2021 OPERATORE MACCHINE TRADIZIONALI (RETTIF VARESE Science (Other)  
  07/04/2021 REGULATORY AFFAIRS SPECIALIST Switzerland Science (Other)  
  07/04/2021 OPERAIO/A SETTORE CHIMICO VICENZA Science (Other)  
  06/04/2021 ADDETTO/A LABORATORIO ANALISI TREVISO Science (Other)  
  02/04/2021 ADDETTO LABORATORIO CHIMICO BRESCIA Science (Other)  
  02/04/2021 SMERIGLIATORE BRESCIA Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO LATINA E FROSIN LATINA Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO LECCE LECCE Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO GENOVA GENOVA Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO LA SPEZIA LA SPEZIA Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO IMPERIA IMPERIA Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO BRESCIA BRESCIA Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO VERONA VICENZA PADOVA Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO MILANO MILANO Science (Other)  
  01/04/2021 INFORMATORE SCIENTIFICO TOSCANA FIRENZE Science (Other)  
  22/03/2021 Periti Chimici PISA Science (Other)  
tutorial candidati
Tutorial italianotutorial lavoro
English tutorialtutorial lavoro