Drug Safety Specialist – Japanese
Parexel | Hyderabad & Bengaluru (Remote/Hybrid)
About Parexel
Parexel is a global leader in clinical research and regulatory services, dedicated to accelerating the development of new therapies to improve global health. We offer a collaborative and supportive environment where your contributions make a real difference.
Job Description
We are seeking a motivated and detail-oriented Drug Safety Specialist with fluency in Japanese (JLPT N2 or above) to join our growing pharmacovigilance team. In this role, you will be responsible for processing adverse event reports, ensuring regulatory compliance, and collaborating with global teams. You will contribute to the safety monitoring of pharmaceutical products, playing a vital role in patient safety.
Key Responsibilities:
- Maintain up-to-date knowledge of drug safety regulations, SOPs, and global reporting obligations.
- Process incoming adverse event reports from various sources, including Eudravigilance and literature.
- Perform triage, data entry, MedDRA coding, and causality & seriousness assessments.
- Prepare case narratives, conduct quality checks, perform reconciliation, and monitor compliance metrics.
- Support regulatory affairs submissions, pharmacovigilance reporting, and literature searches.
- Mentor new team members and collaborate with global PV teams, including Japanese-speaking teams.
- Assist with audits, inspections, and project-specific safety procedures.
Qualifications & Skills:
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, or a related field.
- Languages: Fluency in English and Japanese (JLPT N2 or higher is required).
- Experience:
- Prior experience in drug safety/pharmacovigilance is desirable.
- Knowledge of PMDA PV activities is preferred.
- Skills:
- Excellent communication, teamwork, and organizational skills.
- Strong analytical and problem-solving abilities.
- Familiarity with MS Office, drug safety databases, and literature search tools.
- Strong understanding of medical terminology.
Benefits of Working at Parexel:
- Be part of a global leader in clinical development and pharmacovigilance.
- Opportunity to collaborate with Japanese and international teams.
- Remote/hybrid work flexibility in India.
- Competitive compensation package (based on experience).
- Professional growth through training, mentorship, and global exposure.
Salary:
INR 8 – 14 LPA (depending on experience)