Job Summary
Cognizant is seeking a detail-oriented and motivated Pharmacovigilance Specialist to support safety case processing, case assessment review, and PMDA reporting activities for global pharmaceutical clients. The successful candidate will be responsible for evaluating adverse event reports, performing J-Assessments, managing safety data within Argus/Argus J, and ensuring compliance with regulatory requirements and quality standards.
This role requires strong pharmacovigilance knowledge, attention to detail, and the ability to work effectively in a fast-paced, client-focused environment.
Key Responsibilities
Safety Case Processing & Assessment
- Receive and review safety case reports from multiple sources, including healthcare professionals, medical representatives, call centers, clinical trials, post-marketing surveillance programs, literature, and other reporting channels.
- Perform case assessment and review activities in accordance with client requirements, SOPs, and regulatory guidelines.
- Conduct duplicate case searches and reconciliation activities as required.
- Open, process, and maintain safety cases routed through the global safety database/system.
- Ensure accurate and complete data entry within Argus and Argus J.
J-Assessment & PMDA Reporting
- Perform J-Assessments in Argus J in accordance with Japanese regulatory requirements.
- Prepare and generate PMDA submission reports outside of Argus when required.
- Generate PMDA submission XML files using the designated ICSR Creation Tool for cases where PMDA reports cannot be generated directly through Argus J.
- Maintain submission-related documentation and ensure compliance with reporting timelines.
- Apply local product labeling information for each adverse event by referring to approved product labeling documents.
Operational Excellence
- Collaborate closely with Team Leads and cross-functional teams to support operational activities.
- Provide status updates and progress reports to the Operations Manager as required.
- Ensure timely completion of assigned activities while maintaining quality and productivity standards.
- Support process improvement initiatives and contribute to operational efficiency.
- Maintain compliance with client, regulatory, and internal quality requirements.
Required Experience
Mandatory
- Minimum 1 year of experience in Case Assessment Review, Safety Case Processing, or Pharmacovigilance operations.
- Experience working with safety databases such as Argus or Argus J.
- Experience reviewing and processing adverse event reports.
Preferred
- Minimum 2 years of Pharmacovigilance experience within a global pharmaceutical company, CRO, or healthcare organization.
- Experience with Japanese Pharmacovigilance regulations and PMDA reporting requirements.
- Experience performing J-Assessments and managing regulatory submissions.
Educational Qualifications
One of the following qualifications is required:
- Bachelor's Degree in Life Sciences or Non-Life Sciences; or
- Nursing qualification/license; or
- Degree in Pharmacy, Medicine, Allied Health Sciences, or related healthcare disciplines.
Language Requirements
Japanese
- Native-level Japanese proficiency; or
- Japanese Language Proficiency Test (JLPT) N1 or equivalent.
English
- Business-level English proficiency (Reading, Writing, and Listening).
- TOEIC score of 700 or above preferred.
- Overseas education or study-abroad experience is an advantage.
Required Competencies
- Strong analytical and problem-solving skills.
- Excellent attention to detail and accuracy.
- Strong verbal and written communication skills.
- Ability to work effectively in a team environment.
- Good organizational and time-management skills.
- Demonstrated learning agility and willingness to acquire new skills and knowledge.
- Ability to manage multiple priorities while maintaining high-quality standards.
- Commitment to compliance, quality, and patient safety.
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。
