Experience required: 5 to 9 years
- Preparation of periodic safety reports, PADERs, for the USA regulatory agency (FDA).
- Medical review of PADERs.
- Quality control of PADERs.
- Administrator, Quality Approver, Submitter, Writer, MD, QC role in the TrackWise system.
- Maintenance of the TrackWise system.
- Literature review for NDA Annual Reports submitted to the FDA.
- Preparation of Standard Operating Procedure (SOP) documents, Working Instructions (WI), and Manuals.
- Inspection/audit interviewee.
- Other tasks assigned by the direct manager.
- Bioscience background
- Active knowledge of English language
- MS Office skills
- Sound medical knowledge and medical judgment
- Experience in medical writing
- Excellent organizational skills
- Excellent presentation and communication skills
- Minimum 4 years of experience in pharmacovigilance.
Apply through this Link