Life Science : PV Aggregate Reporting : Pune / Mumbai : Apply Now

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.