Are you fluent in Japanese (JLPT N2 or above) and passionate about drug safety and pharmacovigilance? Parexel, a global leader in clinical research and regulatory services, is hiring for the position of Drug Safety Specialist – Japanese in Hyderabad and Bengaluru (Remote/Hybrid options available).

This role is perfect for professionals in life sciences, pharmacovigilance, or drug safety, looking to expand their career with a reputed multinational.

Key Responsibilities

As a Drug Safety Specialist (Japanese) at Parexel, you will:

• Maintain knowledge of drug safety regulations, SOPs, and global reporting obligations.
• Process incoming adverse event reports from multiple sources including Eudravigilance and literature.
• Perform triage, data entry, MedDRA coding, causality & seriousness assessments.
• Prepare case narratives, quality checks, reconciliation, and compliance metrics.
• Support regulatory affairs submissions, PV reporting, and literature searches.
• Mentor new recruits and collaborate with global PV teams, including Japanese-speaking teams.
• Assist with audits, inspections, and project-specific safety procedures.

Qualifications & Skills

• Education: Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, or related field.
• Languages: Proficiency in English + Japanese (JLPT N2 or higher required).
• Experience:
  • Prior experience in drug safety / pharmacovigilance desirable.
  • Knowledge of PMDA PV activities preferred.
  • Strong medical terminology knowledge.
• Skills:
  • Excellent communication, teamwork, and organizational skills.
  • Strong analytical and problem-solving abilities.
  • Familiarity with MS Office, drug safety databases, and literature search tools.

Benefits of Working at Parexel

• Work with a global leader in clinical development and pharmacovigilance.
• Opportunities to collaborate with Japanese and international teams.
• Remote/hybrid work flexibility in India.
• Competitive compensation package (expected range: INR 8–14 LPA, based on experience).
• Professional growth through training, mentorship, and global exposure.

How to Apply

Application Link