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.
