**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. Cognizant is an equal chance employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.