跳到主要內容

SDM-IOA Delivery

00069302671

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.


关于高知特 (Cognizant)
高知特(Cognizant)(纳斯达克代码:CTSH)作为一家AI Builder和相关技术服务提供商,致力于通过打造全栈AI解决方案,帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长,将企业独特的业务场景融入科技系统,赋能组织释放人才潜能,推动切实成果,并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情,敬请访问 cognizant.ai 或关注@cognizant。

补充雇佣信息
薪酬信息截至本职位发布之日为准。Cognizant 保留在适用法律允许的范围内随时修改该信息的权利。
申请人可能需要通过现场面试或视频会议的方式参加面试。此外,候选人在每次面试时可能需要出示其当前所在州或政府签发的有效身份证件。
Cognizant 是一家提供平等就业机会的雇主。在招聘过程中,您的申请和候选资格不会因种族、肤色、性别、宗教、信仰、性取向、性别认同、国籍、残疾、遗传信息、怀孕、退伍军人身份或任何其他受联邦、州或地方法律保护的特征而受到影响。

帮助您蓬勃发展与成长的福利

我们的福利计划以您为中心打造——帮助您享受充实、平衡且健康的生活。
有葉子的植物的藍色線條圖

财务健康

我们会定期审查市场数据,确保薪酬体现您所带来的价值。您的福利不仅限于薪资,还可能包括退休计划、财务教育等。

Stay Healthy Midnight Blue RGB

身心健康

我们通过带薪休假、在条件允许下的灵活工作安排、医疗保障计划、心理咨询、心理健康盟友计划等,赋能您将身心健康放在首位。

Build The Career You Want Midnight Blue RGB

您的职业发展,由您做主

在 Cognizant 提供的 35 万多个岗位中,您将有机会探索新的技术、行业和工作地点,并打造推动职业发展的关键技能。

Making A Meaningful Impact Midnight Blue RGB

现实世界的影响力

想想您所依赖的那些知名品牌。很可能,他们也依赖我们来帮助强化其业务。在这里,您将把大胆的想法转化为改善全球生活的解决方案。

还没有找到合适的机会吗?

获取为您量身定制的最新职位机会、招聘活动和公司新闻!

掌握最新动态