Remote Job Parexel Hiring for Drug Safety Specialist
Company: Parexel
Job Title: Drug Safety Specialist – Japanese
Location: India (Remote)
Job ID: R0000035627
Department: Medical Sciences
Job Type: Full-Time
About Parexel
Parexel is a global leader in clinical research and healthcare intelligence, dedicated to improving patient outcomes through innovation and collaboration. With decades of experience in clinical development, regulatory affairs, and pharmacovigilance, Parexel partners with leading biopharmaceutical companies to deliver life-changing therapies around the world. Remote Job Parexel Hiring for Drug Safety Specialist
At Parexel, you’ll work with talented professionals who share a deep commitment to science, quality, and patient safety. If you’re passionate about drug safety, regulatory science, and working in a collaborative, international environment — this role is for you. Remote Job Parexel Hiring for Drug Safety Specialist
Position Overview
The Drug Safety Specialist – Japanese will be responsible for managing pharmacovigilance (PV) activities, including case processing, safety data analysis, literature surveillance, and global safety reporting. Remote Job Parexel Hiring for Drug Safety Specialist
This position requires fluency in Japanese (JLPT N2 or higher) and proficiency in English, as it involves reviewing and processing safety data from Japanese and global sources in compliance with international PV regulations. Remote Job Parexel Hiring for Drug Safety Specialist
You will work closely with global and Japanese-speaking teams to ensure high-quality safety reporting, compliance with regulatory requirements, and effective communication across stakeholders. Remote Job Parexel Hiring for Drug Safety Specialist
Key Responsibilities
1. General Responsibilities
- Maintain up-to-date knowledge of assigned drugs’ adverse event profiles, safety labeling, and global safety regulations.
- Ensure compliance with client SOPs, guidelines, and global pharmacovigilance reporting obligations.
- Assist in developing project-specific safety procedures, workflows, and documentation templates.
- Participate in internal and external audits, inspections, and training sessions.
- Provide mentorship to new recruits and delegate tasks as appropriate.
- Collaborate with client-side teams to ensure timely and accurate project delivery.
- Track and maintain compliance with key performance metrics and internal SLAs.
2. Case Processing
- Monitor incoming safety reports from multiple sources, including mailboxes, EudraVigilance, and literature databases.
- Conduct triage of case reports for completeness, validity, and accuracy.
- Perform medical and data consistency checks to ensure cohesive case narratives.
- Enter accurate data into global safety databases according to client conventions and SOPs.
- Evaluate and document causality, expectedness, and seriousness for adverse events.
- Perform MedDRA coding according to “MedDRA Term Selection: Points to Consider.”
- Generate high-quality case narratives and conduct follow-ups when required.
- Perform quality control (QC) and validation checks on safety data.
- Support literature search activities and ensure data reconciliation with data management teams.
- Generate line listings and tabulations for Periodic Safety Reports (PSRs) and ad hoc reports.
- Support compliance investigations for late case reporting to health authorities.
3. Drug Safety Reporting
- Conduct quality control of case reports, listings, and tabulations.
- Develop expedited reporting procedures in line with regulatory requirements.
- Manage electronic safety report submissions to regulatory authorities, ethics committees, and investigator sites.
- Track and file submission records while maintaining compliance documentation.
- Collaborate with the Global PV Information Office for regulatory submissions and global reporting coordination.
- Collect and analyze compliance metrics related to ICSR submissions.
- Remote Job Parexel Hiring for Drug Safety Specialist
4. Regulatory Affairs Support
- Validate and update regulatory databases with product lifecycle information, including manufacturing sites, storage conditions, and packaging updates.
- Manage and track labeling variations, product renewals, and application updates in client systems.
- Generate reports for affiliates and agencies (e.g., EMA) and maintain marketing authorization records.
- Conduct xEVMPD submissions via EMA Gateway and track acknowledgments.
- Coordinate with regulatory teams to ensure accurate documentation and alignment with current SmPCs.
- Remote Job Parexel Hiring for Drug Safety Specialist
5. Literature Search and Review
- Develop and maintain comprehensive literature search strategies based on client parameters.
- Conduct systematic literature reviews for safety signal identification and DSUR/PSUR submissions.
- Maintain records of local and international scientific journals in scope for literature monitoring.
- Perform quality checks on search strategies and implement database updates as needed.
- Communicate effectively with internal and external stakeholders to resolve literature-related queries.
- Remote Job Parexel Hiring for Drug Safety Specialist
Skills and Competencies
- Strong understanding of pharmacovigilance principles and global drug safety processes.
- Knowledge of ICH guidelines, GVP modules, and PMDA safety reporting requirements.
- Expertise in medical terminology and safety data evaluation.
- Excellent analytical, problem-solving, and data interpretation skills.
- Proficiency in performing database and literature searches.
- Strong interpersonal and communication skills in both Japanese and English.
- Excellent organization, prioritization, and multitasking abilities.
- Proficiency in MS Office (Word, Excel, PowerPoint) and web-based applications.
- Client-focused, detail-oriented, and proactive in approach.
Education and Experience
- Bachelor’s or higher degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, or related field.
- Degree in Medicine, Dentistry, Nursing, or Physiotherapy will be an advantage.
- Prior experience in Pharmacovigilance or Drug Safety preferred.
- Strong knowledge of medical terminology.
- Fluency in Japanese (JLPT N2 or higher) is mandatory.
- Experience with PMDA PV activities and working with Japanese-speaking PV teams is desirable.
Why Join Parexel?
- Opportunity to work in a global pharmacovigilance team with exposure to Japanese and international safety processes.
- Comprehensive learning and development programs for career growth.
- Flexible remote working environment with global collaboration.
- Chance to contribute to life-changing research and safety programs that impact global health.
- Remote Job Parexel Hiring for Drug Safety Specialist
How to Apply
Interested candidates can apply directly through Parexel’s official careers portal using Job ID R0000035627.
Visit Parexel Careers to explore more opportunities in drug safety and pharmacovigilance. Remote Job Parexel Hiring for Drug Safety Specialist
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