Drug Safety Specialist – Japanese
Primary Location: India (Remote)
Job ID: R0000035627
Category: Medical Sciences
Work Mode: Remote
Company Overview
Parexel is a global provider of clinical research and drug development services, supporting life sciences companies to improve patient outcomes and ensure regulatory compliance.
Job Overview
The Drug Safety Specialist – Japanese provides pharmacovigilance support for assigned drugs. Responsibilities include case processing, regulatory reporting, literature review, compliance monitoring, and quality oversight, with a focus on Japanese-language safety data and regulatory requirements.
Key Responsibilities
1. General
Maintain knowledge of assigned drugs’ adverse event profiles, labeling, client guidelines, SOPs, and global drug safety regulations.
Ensure compliance with internal and regulatory timelines for adverse event reporting.
Develop and support project-specific safety procedures, workflows, and templates.
Attend/conduct internal and client training sessions.
Participate in audits and inspections: preparation, participation, and follow-up.
Delegate work to Drug Safety Assistants when required.
Liaise with client teams to ensure high-quality deliverables.
Identify concerns and escalate to senior management.
Mentor new team members and manage document archiving.
Respond to clients/customers in a timely manner.
2. Case Processing
Monitor incoming safety reports from mailboxes, EudraVigilance, literature searches, etc.
Triage reports for completeness, legibility, and validity.
Assess medical consistency and compare with client database records.
Add new products or remove withdrawn/expired products from client tools.
Create and accurately enter cases into the safety database.
Ensure expectedness, causality, and seriousness criteria are correct.
Apply MedDRA coding according to guidelines.
Perform query management and prepare case narratives.
Conduct case reconciliation with Data Management.
Generate line listings and tabulations for safety reports.
Support compliance for ICSRs, including late case investigations and corrective actions.
3. Drug Safety Reporting
Conduct quality control of case reports, line listings, and tabulations.
Develop expedited reporting procedures and maintain local reporting requirements.
Register with relevant authorities for electronic reporting.
Submit safety reports to investigators and track submissions.
Perform unblinding of SUSARs as required.
Collect and report compliance metrics.
4. Regulatory Affairs
Compare client data with database content and update missing information.
Maintain product lifecycle details in regulatory databases (strength, packaging, sites, shelf life, etc.).
Track labeling, quality, and administrative changes; create references for health authority responses.
Generate and dispatch regulatory reports; track submission status.
Perform xEVMPD submissions via EMA Gateway and validate content against SmPC.
5. Literature Search & Review
Formulate and maintain literature search strategies per client requirements.
Retrieve, review, and enter valid cases into the database.
Maintain local journals in scope for literature searches.
Perform quality checks on search strategies and journals.
Periodically review database thesauri and update search strategies.
Interact with internal/external contacts to resolve literature-related issues.
Required Skills & Competencies
Sound knowledge of drug safety and drug development processes.
Ability to interpret and apply global safety regulations.
Experience in data analysis and evaluation of safety data.
Strong presentation, analytical, and problem-solving skills.
Clear understanding of regulatory submission processes.
Excellent interpersonal, organizational, and prioritization skills.
Proficiency in database/literature searches, MS Office, and web-based applications.
Client-focused and collaborative; able to manage multiple priorities.
Education & Experience
Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.), or relevant PV experience.
Advantage: Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing.
Relevant experience in drug safety/pharmacovigilance.
Good knowledge of medical terminology.
Japanese Language Proficiency: JLPT N2 or above (required).
Experience with PMDA PV activities and Japanese-speaking PV case processing teams.
Application
Apply Now
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Berlin |Baden-Wurttemberg :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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