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Patient Safety Specialist

Transperfect
Transperfect
0-3 years
preferred by company
Delhi, India
1 May 14, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Patient Safety Specialist (Japanese Language Required)
Location: Delhi, India
Work Model: On-site / Hybrid / Remote
Employment Type: Freelance
Department: Recruitment / Pharmacovigilance / Drug Safety


Job Overview

A global opportunity is available for a Patient Safety Specialist (Japanese Language Required) to support international pharmacovigilance operations across clinical development and post-marketing safety programs. This role is ideal for professionals passionate about patient safety, drug safety surveillance, regulatory compliance, and global pharmacovigilance processes.

The selected candidate will collaborate with international safety teams to ensure timely case processing, regulatory reporting, literature monitoring, affiliate coordination, and safety intelligence activities while maintaining compliance with global and local pharmacovigilance standards.

This opportunity is particularly suited for candidates with Japanese language proficiency seeking to build or advance their careers in drug safety, pharmacovigilance, patient safety operations, and clinical safety compliance.


Key Responsibilities

Safety Case Management

  • Process and manage individual case safety reports (ICSRs) for clinical trial and post-marketed pharmaceutical products
  • Ensure accurate documentation, assessment, and follow-up of adverse event cases
  • Maintain data quality and compliance with internal pharmacovigilance workflows

Regulatory Compliance & Reporting

  • Support pharmacovigilance regulatory submissions as per international and local requirements
  • Assist in safety documentation preparation and regulatory communication activities
  • Ensure compliance with applicable global drug safety regulations and SOPs

Literature Surveillance

  • Conduct scientific and medical literature reviews for safety signal identification
  • Track potential adverse events and relevant safety findings from published sources
  • Escalate important safety information appropriately

Global Affiliate Coordination

  • Collaborate with regional and global affiliates for pharmacovigilance activities
  • Support safety data exchange and follow-up communications
  • Maintain strong cross-functional communication with internal stakeholders

Safety Intelligence & Continuous Improvement

  • Contribute to safety intelligence reporting and signal monitoring
  • Identify operational improvement opportunities within pharmacovigilance workflows
  • Support process optimization and quality enhancement initiatives

Required Qualifications

Educational Requirements

  • Bachelor’s or equivalent degree in:
    • Life Sciences
    • Pharmacy
    • Nursing
    • Medicine
    • Biotechnology
    • Healthcare-related disciplines

Equivalent relevant professional experience may also be considered.