Job Summary
Contribute to medical safety activities within a global pharmaceutical environment by supporting end to end safety case review and documentation for clinical and post marketing products. Apply knowledge of pharma research and development and pharmacovigilance operations to ensure robust assessment of individual case safety reports while collaborating in a hybrid work model to uphold patient safety and regulatory compliance across diverse therapeutic areas.
Responsibilities
Perform systematic medical safety review of individual case safety reports to ensure accurate assessment of seriousness causality and clinical relevance in alignment with internal standards and global regulatory expectations.Apply foundational knowledge of pharma research and development to interpret clinical trial data product labels and risk benefit profiles when evaluating reported adverse events and safety signals.Execute end to end case processing activities including medical evaluation narrative refinement coding verification and consistency checks to maintain high quality safety data within applicable systems.Conduct thorough verification of source documents and supporting clinical information to confirm case validity completeness and coherence while escalating unclear or conflicting data for clarification.Participate in routine safety review meetings by providing concise case level insights that support aggregate safety assessments risk mitigation strategies and regulatory submissions.Adhere strictly to established pharmacovigilance workflows and standard operating procedures to ensure timely case processing within agreed service levels and compliance with global health authority requirements.Collaborate with cross functional pharmacovigilance and safety operations teams to clarify medical details resolve data discrepancies and support continuous improvement of safety review practices.Maintain meticulous documentation of case handling decisions rationale and follow up actions to enable transparent audit trails and facilitate inspections or internal quality reviews.Utilize safety databases and relevant tools to retrieve analyze and update case information while ensuring accurate coding and classification of events products and medical history.Contribute to signal detection and risk evaluation activities by highlighting unusual patterns medically significant events or emerging trends observed during case review activities.Support hybrid work model expectations by coordinating effectively through digital collaboration platforms and maintaining consistent communication with team members during day shift operations.Advance patient safety outcomes by ensuring that each processed case supports reliable safety profiles which inform healthcare professionals regulators and internal stakeholders.Engage in continuous learning related to evolving pharmacovigilance regulations medical safety methodologies and product specific knowledge to strengthen the quality of case evaluations.
Qualifications
Possess academic background in life sciences pharmacy medicine or a related discipline that enables sound understanding of clinical concepts and therapeutic areas relevant to medical safety.Demonstrate practical experience or training in pharmacovigilance and safety operations with direct exposure to case processing workflows and medical review principles even at an entry level.Show applied familiarity with pharma research and development processes including clinical trial phases key endpoints and safety data collection practices that support robust case evaluation.Exhibit capability to perform medical safety review for individual case safety reports using structured assessment techniques and clear documentation of clinical reasoning.Communicate effectively in English through clear written narratives and spoken interactions to present case findings collaborate with stakeholders and support regulatory compliant documentation.Display strong attention to detail analytical thinking and accountability in managing safety data ensuring consistency accuracy and reliability across all handled cases.Adapt to hybrid work arrangements and day shift schedules while using collaboration tools productivity applications and safety systems to maintain seamless case processing and team coordination.
Certifications Required
Preferred certification in pharmacovigilance or drug safety such as professional training in Good Pharmacovigilance Practices or equivalent industry recognized programs.
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。
