Field | Details |
Role Title | SDM |
Essential Educational Qualification and Experience | • Bachelor’s degree. Life sciences or medical degree preferred. |
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.
Acerca de Cognizant
Cognizant (Nasdaq: CTSH) es un creador de soluciones de IA y proveedor de servicios tecnológicos que conecta la inversión en IA con el valor empresarial mediante el desarrollo de soluciones de IA full‑stack para sus clientes. Su profundo conocimiento de la industria, junto con su experiencia en procesos e ingeniería, permite incorporar el contexto único de cada organización en sistemas tecnológicos que amplifican el potencial humano, generan resultados tangibles y mantienen a las empresas a la vanguardia en un entorno en constante cambio. Más información en cognizant.ai o @cognizant.
Información adicional de empleo
La información de compensación es precisa a la fecha de esta publicación. Cognizant se reserva el derecho de modificar esta información en cualquier momento, sujeto a la legislación aplicable.
Es posible que se requiera que los solicitantes asistan a entrevistas en persona o por videoconferencia. Además, es posible que se requiera que los candidatos presenten su identificación actual emitida por el estado o gobierno durante cada entrevista.
Cognizant es un empleador que ofrece igualdad de oportunidades. Tu solicitud y candidatura no serán consideradas en base a raza, color, sexo, religión, credo, orientación sexual, identidad de género, origen nacional, discapacidad, información genética, embarazo, condición de veterano o cualquier otra característica protegida por las leyes federales, estatales o locales.
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