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PV Associate

PV Associate

Job Title: PV Associate
Contract Type: Contract
Location: Cambridge, Cambridgeshire
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: PVA 01_1489568378
Contact Name: Alex Young
Contact Email: a.young@sciproglobal.com
Job Published: March 15, 2017 08:59

Job Description

Key attributes/Skills/Education

  • The candidates will ideally be a life sciences graduates and have experience of working in Pharmacovigilance.
  • Competent with medical terminology, excellent communication abilities and possess good IT skills.
  • Previous use of a safety database (preferably ARISg or Argus web based) is required.
  • A high standard of organisation, narrative writing and impeccable attention to detail is essential.

This is an excellent opportunity for candidates seeking to broaden their safety knowledge in both a clinical trial and post-marketing setting and to be part of a progressive department.

Working in a global Pharmacovigilance Department the candidates will gain exposure to many different aspects of Pharmacovigilance. Following induction to the company and training, the Pharmacovigilance Associates will be responsible for:

  • Case processing including data entry, narrative writing, review and assessment of SAE/AE reports from all sources (incl. clinical trial and post marketing) onto our global safety database.
  • MedDRA coding.
  • Case submissions to regulatory authorities.
  • SAE reconciliation.
  • Literature review.
  • Using and maintaining the global safety database.
  • Contributing to the ongoing enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
  • Safety data retrieval, supporting information requests production of data for aggregate reports.
  • Supporting the Pharmacovigilance team with the production and quality control of safety reports in CSRs, DSUR/PSURs, and regulatory dossiers (MAA/NDA).
  • The candidates will ideally be a life sciences graduates and have experience of working in Pharmacovigilance.
  • Competent with medical terminology, excellent communication abilities and possess good IT skills.
  • Previous use of a safety database (preferably ARISg or Argus web based) is required.
  • A high standard of organisation, narrative writing and impeccable attention to detail is essential.

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