Drug Safety Division (regulatory Affairs)

• Review of task and allocation of assignments to team members
• Analyse performance of team members periodically to ensure compliance with organizational SOP, regulatory guidelines and quality metrics
• Identify training needs for the new employee/ team members to ensure quality and accuracy in activities handled
• Co-ordinate with legal department for signing CDA, MSA and SOW with the vendor
• Monitor performance of vendor as per SOW, KPI s and SOPs
• Attend weekly calls with vendors and ensure timely escalation of outstanding issues
• Perform periodic/ as- hoc audit of the vendors
• Assist in the development of departmental SOP's and work instructions
• Review of PADERs, PBRERs and PSURs
• Involvement in signal detection activities and in DSRC meetings
• Configure product, study, formulation in Argus database as per requirement
• Perform periodic and frequent review of Argus database as per requirement
• Perform periodic and frequent review of Argus database to determine status of reportable cases by generating of line listing as per SOP
• Assign PADERs to the team members at the start of the month
• Through knowledge of Pharmacovogilance activities

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