Patient Safety Associate II (Pharmacovigilance)

Roles & Responsibilities
• Maintain knowledge of assigned products’ safety profiles, labeling, SOPs, and global PV regulations
• Ensure compliance with global regulatory reporting timelines and internal procedures
• Support development of project-specific safety workflows, templates, and procedures
• Participate in audits, inspections, training sessions, and LMS requirements
• Process Individual Case Safety Reports (ICSRs): triage, data entry, coding, narratives, QC, and follow-up
• Monitor incoming safety reports from mailboxes, EudraVigilance, affiliates, and literature
• Perform MedDRA coding, causality, seriousness, and expectedness assessments
• Conduct literature searches, screening, and case entry as per search strategy
• Generate line listings, tabulations, and support periodic and ad-hoc safety reports
• Support compliance activities, late case investigations, and metrics reconciliation
• Submit safety reports to health authorities, ethics committees, and investigators
• Support regulatory database activities including lifecycle tracking, variations, and xEVMPD submissions
• Collaborate with global teams, clients, and affiliates to ensure high-quality deliverables
• Mentor junior team members and support project-related activities as required

Qualification
• Degree in Life Sciences, Pharmacy, Biomedical Sciences, or related field
• Medical, Nursing, Dentistry, or allied healthcare degree is an added advantage

Experience
• Experience in pharmacovigilance or drug safety is preferred
• Exposure to ICSR processing, literature review, reporting, or regulatory databases is desirable
• Experience with Japanese PV activities and PMDA requirements is an advantage

Skills
• Strong knowledge of drug safety regulations and pharmacovigilance processes
• Ability to interpret and apply global regulatory requirements
• Excellent written and verbal communication skills (English; Japanese JLPT N2 or above preferred)
• Good analytical, organizational, and problem-solving skills
• Proficiency in PV databases, literature searches, and MS Office tools
• Ability to manage multiple tasks and work effectively in a global team environment
• Client-focused mindset with strong attention to quality and compliance

About the organization
Parexel is a leading global clinical research organization dedicated to improving world health by supporting the development of innovative therapies. With expertise across clinical research, regulatory, and pharmacovigilance services, Parexel partners with biopharmaceutical companies worldwide to deliver patient-focused, high-quality solutions.