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Job Details

Pharmacovigilance Associate

Company: CROMSOURCE
Location:  ITALY
Reference: HQ00001139
Closing Date: 18 Feb 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Job Title: Pharmacovigilance Associate Location: Verona, Italy Schedule: Office Based Main Job Tasks and Responsibilities Cooperates in the collection of the Serious Adverse Event (SAE) arisen during clinical investigations and during clinical trial Performs the handling of queries/questions in case of need of further information to complete or to understand the AE/SAE and manages the follow-up for ensuring efficient control and information flow Supports the preparation of...

Requirements:

Job Title: Pharmacovigilance Associate

Location: Verona, Italy

Schedule: Office Based

Main Job Tasks and Responsibilities

  • Cooperates in the collection of the Serious Adverse Event (SAE) arisen during clinical investigations and during clinical trial
  • Performs the handling of queries/questions in case of need of further information to complete or to understand the AE/SAE and manages the follow-up for ensuring efficient control and information flow
  • Supports the preparation of case narratives, CIOMS I Forms, SAE Forms and all other applicable forms in order to perform safety reporting
  • Supports the reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR), arisen during clinical trials, to Competent Authorities (CAs), Ethics Committees (ECs) and other recipients ensuring compliance with applicable regulations and appropriate handling
  • Manages the unblinding information
  • Supports the periodic reporting to CAs, ECs and other recipients of safety documentation, ensuring compliance with applicable regulations and appropriate handling
  • Supports the safety reporting of reportable safety issues (SAE) arisen during clinical studies with medical devices to CAs, ECs and other recipients, ensuring compliance with applicable regulations and appropriate handling
  • Supports the preparation and reviewing of Safety Plans and AE/SAE Reconciliation Plan
  • Writes the SOPs and Working Instructions in order to implement safety policy
  • Supports in evaluating the performance of AE/SAE reconciliation process between project-specific clinical databases and safety databases ensuring consistent information
  • Supports the set-up of safety database in order to make sure it meets all safety requirements

Education and Experience

  • University Degree in scientific medical or paramedical discipline
  • Up to three (3) years of safety experience in the CRO/Pharmaceutical industry
  • Excellent understanding of safety regulations in EU Member States (e.g. ICH, CT3, MDD, AIMDD, MEDDEVs) and implementation in national laws
  • Fluent in English
  • Ability to research safety requirements in International and National Regulation
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook

If you would like to be considered for this exciting opportunity pleased send your CV directly to myna.yeboah@cromsource.com

Why CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

Pharmacovigilance Associate Pharmacovigilance Scientist Drug Safety Officer Drug Safety Associate Drug Safety Scientist PV Italy

Drug Safety Associate

Apply for this job: Pharmacovigilance Associate

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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