PV Aggregate Reporting
Location: MumbaiSalary – Upto15 LPA (Depends on last Salary)
5 Days Work
2 Days Rotational Off
Cabs Available
Night Shift Allowance
Job Descriptions
- 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