Drug Safety Associate-Quality management

BiosTec

Bangalore, Karnataka, Inde

Profile description:

BiosTec is looking for candidates who can fill the position of Drug Safety Associate. The role will be involved in the below mentioned activities
• Responsible for establishing quality management system in line with worldwide pharmacovigilance legislation
• Responsible for the preparation and maintenance of pharmacovigilance standard operating procedures (SOPs), work instructions and policies
• Preparation of training plans and maintenance of training records
• Preparation of compliance matrix and identification of non-adherence to the quality requirements of PV system
• Deviation, CAPA and change control management.
• Quality review of individual case safety reports and aggregated data reports including risk management plan (RMPs), aggregate data reports including periodic safety update reports (PSUR)/periodic adverse drug Experience report (PADER)/development safety update report (DSUR) and other safety reports
• Tracking and documentation of pharmacovigilance... More Detail

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