Job Summary
Serve as a subject matter expert in medical safety within a global pharmaceutical environment applying research and development knowledge to support safe and effective product development. Contribute to risk assessment safety data interpretation and medical review activities in a hybrid work model ensuring day shift engagement and strong collaboration across cross functional teams.
Responsibilities
- Apply medical safety expertise to interpret clinical and nonclinical data from pharma research and development activities ensuring that emerging safety signals are identified and documented with clarity and consistency across assigned products.
- Perform structured medical safety assessments of individual and aggregate case data from clinical trials and postmarketing sources focusing on accurate evaluation of seriousness causality and potential impact on patient safety and regulatory commitments.
- Collaborate with cross functional teams in research and development to provide timely medical safety input on study protocols informed consent documents and safety monitoring plans supporting robust risk mitigation strategies for ongoing projects.
- Review and refine safety related sections of core clinical and regulatory documents including risk management narratives and summary reports ensuring that medical interpretations are scientifically sound and aligned with company safety standards.
- Support signal detection activities by analyzing safety trends preparing concise summaries of safety data and recommending follow up actions that promote continuous improvement in product safety profiles.
- Coordinate with pharmacovigilance and clinical operations partners to clarify case details resolve data inconsistencies and enhance the overall quality and completeness of safety information captured in internal systems.
- Contribute to the preparation of responses for safety related queries from regulatory authorities and internal stakeholders ensuring that explanations are medically justified data driven and aligned with global safety practices.
- Maintain accurate documentation of medical safety decisions rationales and review outcomes in designated tools supporting audit readiness and transparent traceability of safety evaluations across the product lifecycle.
- Participate in cross functional meetings during the day shift to discuss safety topics share insights from ongoing reviews and ensure that safety considerations are integrated into key development and commercialization decisions.
- Support development and refinement of internal medical safety procedures by providing feedback from practical case handling experience helping to streamline workflows and enhance overall efficiency in safety review activities.
- Engage in hybrid work model collaboration using digital communication tools maintaining strong partnerships with global colleagues while ensuring timely delivery of safety assessments and documentation.
- Contribute to the company purpose of bringing safe and effective therapies to individuals and communities by rigorously applying medical judgment to safety data and highlighting potential risks that may affect public health outcomes.
- Pursue continuous learning in medical safety research and development practices and evolving pharmacovigilance requirements to keep safety evaluations current and to support innovative solutions that improve societal health.
Qualifications
- Demonstrate solid experience in pharma research and development with two to three years of hands on involvement in safety related aspects of clinical studies or product development activities.
- Apply practical understanding of adverse event evaluation seriousness assessment and causality reasoning gained from previous roles in medical safety or closely related research functions.
- Utilize working knowledge of pharmacovigilance processes and medical review practices including exposure to PV medical review activities to support high quality case assessments and signal evaluations.
- Employ strong analytical and critical thinking capabilities to interpret complex medical data sets summarize key safety insights and communicate findings clearly to nonmedical colleagues.
- Use effective written and verbal communication skills to prepare structured safety summaries medical narratives and responses for internal and external stakeholders in a concise and comprehensible manner.
- Operate comfortably in a hybrid work environment and day shift setting managing time and tasks independently while staying fully engaged with remote and onsite team interactions.
- Draw on experience with standard safety and clinical data systems such as electronic data capture tools or safety databases to retrieve information verify case details and support accurate documentation.
- Exhibit commitment to ethical medical practice and patient safety by following internal procedures regulatory expectations and scientific principles in every aspect of safety review and documentation.
Certifications Required
Preferred certification in pharmacovigilance or drug safety such as Pharmacovigilance Professional Certification or equivalent.
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。
