Patient Safety Associate II / Patient Safety Specialist Japanese

Roles & Responsibilities
• Maintain working knowledge of adverse event safety profiles, product labeling, client guidelines, SOPs, and global drug safety regulations
• Ensure compliance with global regulatory reporting obligations and internal timelines
• Assist in development of project-specific safety procedures, workflows, and templates
• Attend, conduct, and complete required internal and client training programs
• Support audits and inspections and perform follow-up activities
• Monitor performance metrics and strive to meet client-defined quality standards
• Delegate work to Drug Safety Assistants where applicable
• Liaise with client teams to ensure high-quality pharmacovigilance deliverables
• Identify risks or concerns and escalate to senior management
• Mentor new team members as required
• Archive source documents and safety-related correspondence
• Respond to client and stakeholder queries in a timely manner
• Monitor incoming safety reports from multiple sources including databases and literature
• Perform triage of safety cases for completeness, validity, and medical coherence
• Create and process cases in the safety database with accurate data entry
• Ensure accurate seriousness, expectedness, causality assessment, and MedDRA coding
• Prepare medically coherent case narratives and manage follow-up queries
• Perform quality checks, validation checks, and case reconciliation activities
• Generate line listings and tabulations for safety reports
• Support ICSR compliance activities and late case investigations
• Perform quality control of expedited and periodic safety reports
• Support global and local regulatory safety reporting activities
• Maintain regulatory databases and track product lifecycle changes
• Perform xEVMPD submissions and track acknowledgements
• Conduct literature searches, case identification, and database entry
• Maintain and update literature search strategies and local journal lists
• Perform quality checks on literature search outputs

Qualification
• Degree in Life Sciences, Health Sciences, or Biomedical Sciences
• Medical, Dental, Nursing, Physiotherapy, or related healthcare degree preferred

Experience
• Relevant experience in pharmacovigilance or drug safety preferred
• Experience with PMDA pharmacovigilance activities desirable
• Experience working with Japanese-speaking PV teams preferred

Skills
• Strong knowledge of drug safety and drug development processes
• Understanding of global pharmacovigilance regulations
• Experience in safety data analysis and evaluation
• Proficiency in safety databases and literature search tools
• Excellent analytical, organizational, and problem-solving skills
• Strong interpersonal and client-facing skills
• Excellent written and verbal communication skills
• Proficiency in English and Japanese (JLPT N2 or higher required)
• Ability to manage multiple priorities with attention to detail
• Computer proficiency with MS Office and web-based systems

About the Company
Parexel is a global clinical research organization that partners with biopharmaceutical companies to advance innovative medicines through clinical research, pharmacovigilance, and regulatory expertise. With a strong commitment to patient safety, scientific quality, and regulatory compliance, Parexel supports the full product lifecycle across global markets.