Life Science : PV Aggregate Reporting : Apply Now

• 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 - 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.)
• Working knowledge of MS Office applications
• Flexibility to work as per business requirements.
• Understands and interprets data/information and its practical application.
• Knowledge of industry and business principles related to biopharmaceutical products and combination products.
• Good interpersonal, verbal, and written communication skills