PV Aggregate Reporting

Job Code # 55

Job Location-  Pune

Salary- 10 LPA to 15 LPA

Key skills-
a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.)
b) Qualifications – Health Care Professional OR Masters/bachelor’s degree in Life Sciences/Physician

Job Description-
Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.)
Qualifications – Health Care Professional OR Masters/bachelor’s degree in Life Sciences/Physician
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 years of medical writing work experience including 1 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