Life Science- PV Aggregate
5 Days Work
2 Days Rotational Off
2 Days Rotational Off
Job Description
- To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings.
- Performs activities related to the preparation, writing and review of safety portions of Periodic
- To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor.
- To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline.
- To track and drive the progress of safety periodic reports as per the client defined timelines.
- To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.)
Eligibility
Minimum 2 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.)