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Pharmacovigilance Specialist (Japan)

1 month, 3 weeks ago
Japan
Full-time
Junior
Operations Specialist
Project and Program Management
Apply Now
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001
View All Jobs 9

Description

  • Perform local literature screening in Japan and support additional pharmacovigilance activities.
  • Enter and update records in the validated literature screening system (LITSIS).
  • Prepare journal lists and search strategies for literature screening activities.
  • Screen literature, redact personally identifiable information (PII), and handle valid case safety reports.
  • Manage acknowledgements, filing, and document control for case safety reports and related materials.
  • Prepare, maintain, and share literature screening reports with clients.
  • Maintain reference product information such as SmPC and PIL.
  • Support or oversee vendor-managed local literature screenings when applicable.
  • Act as a primary or secondary project lead depending on the assignment.
  • Coordinate with team leadership and management to manage quality, timeline, and client communication risks.
  • Contribute to internal process improvements and revisions of internal procedures.

Requirements

  • Bachelor’s degree or higher in life sciences, medical, biomedical, or biotechnology sciences.
  • At least 1 year of experience in pharmacovigilance or safety within a pharma company or CRO, or a recent graduate with relevant education.
  • Fluency in Japanese and English, both spoken and written.
  • Proficiency with MS Office.
  • Based in Japan.
  • Strong analytical and problem-solving skills.
  • High attention to detail and accuracy.
  • Ability to work efficiently under pressure and tight deadlines.
  • Excellent planning, time management, and reporting skills.
  • Ability to handle multiple tasks with an innovative mindset.

Benefits

  • Competitive salary based on experience and skills.
  • Full social insurance coverage, including health insurance, pension, employment insurance, and accident insurance.
  • Paid annual leave.
  • Hybrid and remote work options.
  • Career growth opportunities in an international environment.
  • International training opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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