ProductLife Group is looking for a Senior Medical Writer to join its dynamic team to contribute to the activities performed in the Hub:

Role and Responsibilities:

Analysis of data and preparation of ad hoc reports/plans in the framework:

• PADER

• Risk management plan

• Benefit / risk evaluation report

• Signal detection and reporting

• PSUR / PBRER / Addendum to Clinical Overview

• DSUR

• Off label use reports (French requirements)

• PSUSA response

• Literature screening for medical writing reports

• Ad hoc reports from regulatory authority

Review of Medical Writing Reports:

• PADER

• Benefit / risk evaluation report

• Signal report – Simple Complexity

• Off label use reports

• Literature screening for medical writing reports or for level...