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.
コグニザントについて
コグニザント(NASDAQ: CTSH)は、AI Builderおよびテクノロジーサービスプロバイダーとして、お客様にフルスタックのAIソリューションを構築することで、AI投資と企業価値を結ぶ架け橋となっています。業界、ビジネスプロセス、エンジニアリングに関する当社の深い専門知識を活かし、組織固有のビジネス環境をテクノロジー・システムに組み込みます。これにより、人間の可能性を最大限に引き出し、確かな成果を実現するとともに、急速に変化する世界においてグローバル企業が常に一歩先を行くための支援を行っています。 詳細については、cognizant.ai をご覧ください。
雇用に関する追加情報
本募集に記載されている報酬情報は、掲載日時点で正確なものです。Cognizantは、適用される法令に従い、いつでも本情報を変更する権利を留保します。
応募者は、対面またはビデオ会議による面接への参加を求められる場合があります。また、各面接の際に、現在有効な州政府または政府発行の身分証明書の提示を求められる場合があります。
Cognizantは機会均等雇用主です。応募および選考において、人種、肌の色、性別、宗教、信条、性的指向、性自認、国籍、障がい、遺伝情報、妊娠、退役軍人の地位、その他連邦法・州法・地方自治体の法律により保護されるいかなる特性に基づく差別も行いません。







