Life Science - Mumbai, Mumbai City, Pune - Outpace Consulting Services

Outpace Consulting Services Mumbai, Mumbai City, Pune

4 days ago

Full time

Role & responsibilities:

Minimum 2 - 3 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.)
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 Aggregate Safety Reports (PBRER, DSUR etc.).
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.