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Dettaglio offerta lavoro
Titolo:

VIGILANCE MANAGER 50%

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Settore Biologia/Chimica/Farmaceutica
Categoria Ingegnere Biomedico.
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Descrizione

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.

 

Responsibilities

·        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.

 

Requirements

·        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: info@erservices.ch

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Nazione Svizzera
Regione NO ITALY
Provincia NO ITALY
Città Ticino (CH)
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Anni esperienza da 3 a 5
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Per aprire la scheda dell’offerta di lavoro clicca sul titolo.

  Data Titolo offerta lavoro Location Settore  
  17/05/2021 REGULATORY AFFAIRS SPECIALIST Svizzera Biologia/Chimica/Farmaceutica  
  27/07/2021 OPERATORE DI LABORATORIO TRENTO Biologia/Chimica/Farmaceutica  
  26/07/2021 OPERAI DI LINEA CREMONA Biologia/Chimica/Farmaceutica  
  26/07/2021 ADDETTO REPARTO VERNICIATURA LECCO Biologia/Chimica/Farmaceutica  
  26/07/2021 OPERATORE DI IMPIANTO BERGAMO Biologia/Chimica/Farmaceutica  
  23/07/2021 TECNICO DI LABORATORIO CHIMICO VICENZA Biologia/Chimica/Farmaceutica  
  23/07/2021 PERITI MONZA/BRIANZA Biologia/Chimica/Farmaceutica  
  21/07/2021 PERITO CHIMICO ADDETTO ALLA PRODUZIONE BERGAMO Biologia/Chimica/Farmaceutica  
  16/07/2021 TECNICO DI LABORATORIO - CHIMICO MANTOVA Biologia/Chimica/Farmaceutica  
  16/07/2021 TECNICO DI LABORATORIO - CHIMICO BRESCIA Biologia/Chimica/Farmaceutica  
  16/07/2021 PERITO CHIMICO CONDUZIONE IMPIANTI VICENZA Biologia/Chimica/Farmaceutica  
  15/07/2021 ADDETTO DI LABORATORIO LECCO Biologia/Chimica/Farmaceutica  
  15/07/2021 PERITI CHIMICI NEO DIPLOMATI MONZA/BRIANZA Biologia/Chimica/Farmaceutica  
  15/07/2021 PERITO CHIMICO MILANO Biologia/Chimica/Farmaceutica  
  15/07/2021 ADDETTO CAMERA BIANCA MILANO Biologia/Chimica/Farmaceutica  
  13/07/2021 ADDETTO CAMERA BIANCA MILANO Biologia/Chimica/Farmaceutica  
  13/07/2021 PERITO CHIMICO MILANO Biologia/Chimica/Farmaceutica  
  13/07/2021 PERITI CHIMICI - REPARTO PRODUTTIVO MILANO Biologia/Chimica/Farmaceutica  
  12/07/2021 SOSTENIBILITA' AZIENDALE BERGAMO Biologia/Chimica/Farmaceutica  
  09/07/2021 OPERATORE CHIMICO BERGAMO Biologia/Chimica/Farmaceutica  
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