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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:
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- 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
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