Pharmacovigilance Specialist

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.

Over Cognizant  
Cognizant (NASDAQ: CTSH) is een bouwer van AI-oplossingen en een leverancier van technologiediensten. Wij slaan de brug tussen AI-investeringen en ondernemingswaarde door het bouwen van full-stack AI-oplossingen voor onze klanten. Onze diepgaande kennis van sectoren, processen en engineering stelt ons in staat om de unieke context van een organisatie te verankeren in technologische systemen. Deze systemen versterken het menselijk potentieel, realiseren tastbare resultaten en geven wereldwijde ondernemingen een voorsprong in een snel veranderende wereld. Ontdek hoe op cognizant.ai of @cognizant.

Aanvullende arbeidsinformatie
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