Job location: Bangalore

Experience: 4 to 9 years

Job description

• 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.

Qualifications

• 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