SDM-IOA Delivery

Cognizant


Date: 16 hours ago
City: Kolkāta, West Bengal
Contract type: Full time
Field
Details
Role Title
SDM
Essential Educational Qualification and Experience
  • Bachelor’s degree. Life sciences or medical degree preferred.
  • 12-14 years of Pharmacovigilance (PV)/ Clinical Research/Life Science domain experience
Essential Skills
Good knowledge of Pharmacovigilance process, regulations, guidelines, Audits/Inspections
Role-
Assurance (Business Quality Assurance)
  • Review/ approve, control, and maintain SOPs, SWIs, role descriptions and other project specific documents as applicable.
  • Track audit/inspection findings to ensure timely closure.
  • Monitor/ review RCA/CAPAs for deviations/ audit findings/ inspection findings/escalation/issues etc. as per process and within the target completion date.
  • Monitor/review effectiveness checks of cumulative CAPAs and corresponding actions.
  • Ensure appropriate RCAs and CAPAs are implemented for KPIs and SLAs target misses, audit findings etc.
  • Train the team on Quality Management System (QMS) as applicable.
  • Ensure Project Management is in place for project.
  • Perform internal Assessment as per timeline.
  • Perform evaluation of the process/procedures and liaise with operations team for risk assessment for any new activity/site to find out gaps and help in preparation of Mitigation/Improvement plan.
  • Update project leadership with open CAPAs and risks status as per set timelines.
  • Independently evaluate process adherence, quality, and compliance.
  • Supports operations in driving excellence.
  • Participate in all new business transitions and due diligence.
  • Conduct sessions with respective stakeholders.
  • Be Audit ready 24X7 and act as Single Point of Contact for all Audits & Inspections.
Compliance
  • Monitoring of training compliance for all associates in PV engagement.
  • Educate people and make them aware of importance of compliance.
  • Tracking of training file compliance for all associates in PV engagement.
  • Tracking of onboarding and off-boarding documentation for all associates in PV.
  • Monitoring of document compliance across PV engagement.
  • Be Audit ready 24X7 and act as Single Point of Contact for all Audits & Inspections.
  • Perform spot audit checks to monitor CVs and RD compliance.
  • Monitor/review RCA/CAPAs for deviations/audit findings/inspection findings/escalation/issues etc. as per process and within the target action date.
Training
  • Onboarding of new joiners and facilitation of their organization and client training across PV.
  • Facilitate preparation of training schedule of new joiners.
  • Facilitate preparation of job aids.
  • Facilitate refresher training as and when required.
  • Query resolutions.
  • Conducting Project level Training audit.
  • Centralized Compliance wire tracking.
  • Preparation and Maintenance of PGTP.

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