Job Summary
Role involves managing end to end medical safety activities in a hybrid work model for global pharma research and development initiatives with focus on high quality safety data review and risk assessment while ensuring compliance with regulatory standards and supporting effective product benefit risk evaluation for improved patient outcomes and healthcare advancement
Responsibilities
- Manage medical safety review activities for assigned products ensuring consistent evaluation of safety data and timely identification of potential risks to safeguard patient wellbeing and uphold regulatory expectations
- Coordinate safety data collection and documentation for clinical and post marketing settings ensuring accurate entry of information and high quality narratives that support robust safety analyses
- Conduct detailed medical safety assessments of individual case safety reports to confirm clinical relevance and clarity of reported events and to provide meaningful input into aggregate safety evaluations
- Collaborate with cross functional pharma research and development teams to integrate safety insights into study design protocol amendments and development plans enhancing the scientific rigor and ethical standards of projects
- Monitor emerging safety signals from internal databases and external sources and document medical rationale for signal validation escalation and follow up contributing to proactive risk management strategies
- Prepare and review safety related documentation for regulatory submissions and internal governance meetings ensuring alignment with global safety regulations and company standards for medical accuracy
- Support continuous improvement of safety review workflows by proposing enhancements to templates guidance documents and quality checklists that streamline case processing and improve consistency of medical assessments
- Engage with pharmacovigilance case processing teams to clarify medical aspects of complex cases and to ensure that coding seriousness criteria and outcomes are medically sound and aligned with global safety practices
- Contribute to benefit risk assessments by summarizing key safety trends and medical judgments enabling informed decision making on labelling recommendations risk minimisation activities and communication to healthcare professionals
- Utilize hybrid work arrangements effectively by maintaining clear documentation communication and collaboration practices that ensure uninterrupted support for global safety operations during day shifts without travel requirements
- Participate in training and knowledge sharing sessions on evolving pharmacovigilance guidelines therapeutic area insights and internal systems to maintain up to date medical safety expertise that benefits project quality and societal health outcomes
- Provide constructive feedback on safety database outputs dashboards and metric reports to improve the clinical interpretability of safety information and support data driven decisions across research and development programs
- Support ethical and patient centric safety culture by consistently advocating for accurate reporting transparent communication of risks and responsible use of safety data to strengthen trust in medicines and protect communities
Qualifications
- Demonstrate practical experience in pharma research and development with hands on involvement in safety or clinical documentation activities that build strong understanding of drug development and regulatory expectations
- Apply working knowledge of pharmacovigilance case processing workflows including intake data validation coding and follow up activities to support high integrity safety reporting and efficient case management
- Use medical judgment in pharmacovigilance medical review activities such as narrative evaluation seriousness assessment and causality considerations to enhance the clinical depth and value of each case assessment
- Bring familiarity with global safety regulatory frameworks and guidelines relevant to pharmacovigilance to ensure that all safety activities remain compliant and support timely regulatory interactions
- Operate effectively in hybrid work settings using digital collaboration tools structured documentation and proactive communication skills to maintain productivity and alignment with onsite and remote team members
- Leverage strong analytical and problem solving skills to interpret complex clinical data identify meaningful patterns in safety information and propose medically sound recommendations that aid safer use of medicines
- Communicate clearly in written and verbal formats with diverse stakeholders including clinical teams regulatory colleagues and safety operations staff to ensure shared understanding of safety concerns and actions
- Maintain high attention to detail and quality focus in all safety related deliverables safeguarding accuracy completeness and consistency which directly supports public health and company reputation
Certifications Required
Preferred certifications include pharmacovigilance or drug safety credentials such as certification in global pharmacovigilance or clinical research
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。
