|Job Title:||PV Associate|
|Contact Name:||Alex Young|
|Job Published:||July 20, 2017 10:25|
Working in our 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.