Website:
qualitatva.com
Job details:
Company Description Qualitatva Consulting partners with pharmaceutical and healthcare organizations to build audit-ready, resilient systems that prioritize patient safety and patient rights. The firm challenges checklist-driven compliance by positioning it as a system of accountability to the patient, grounded in integrity, scientific rigor, and strong governance. Its core focus areas include GxP audits and regulatory strategy, end-to-end quality and compliance transformation, governance and risk oversight frameworks, and capability building across industry and academia. Qualitatva works to embed compliance into daily operations so that safe, ethical, and reliable outcomes are consistently delivered. As the company expands, it is committed to shaping professionals and organizations that understand true compliance begins and ends with the patient.
Role Description This is a contract, on-site role based in India/Japan for a Japanese N2/N3 proficient professional with pharmacovigilance (PV) experience. The role involves reviewing and processing safety reports, preparing case summaries, and ensuring accurate and timely entry of safety data into PV systems. The individual will translate and interpret Japanese safety-related documents and communications, and liaise with Japanese-speaking stakeholders to clarify case details and regulatory requirements. Daily tasks include supporting signal detection activities, assisting in the preparation of safety reports and regulatory submissions, and contributing to internal audits and quality checks. The role also requires close collaboration with cross-functional teams to strengthen patient safety practices and compliance with global and Japanese PV regulations.
Qualifications
- Strong pharmacovigilance experience, including case processing, safety data review, and familiarity with global and Japanese PV regulations.
- Proficiency in Japanese language at N2/N3 level (JLPT or equivalent), with the ability to read, write, and interpret safety-related documents and communications.
- Knowledge of GxP concepts and quality systems, with an understanding of compliance, audits, and regulatory expectations in the pharmaceutical and healthcare sectors.
- Competence in medical terminology, data interpretation, and documentation, with attention to detail and accuracy in safety reporting.
- Excellent written and verbal communication skills in English, with the ability to work effectively in cross-functional and multicultural teams.
- Ability to work on-site in Bengaluru, manage time effectively, and handle multiple cases and deadlines while maintaining quality and compliance.
- Bachelor’s or Master’s degree in life sciences, pharmacy, medicine, or a related field; prior experience in a PV or drug safety role is highly preferred.
- Familiarity with safety databases and standard office productivity tools; experience in audit or inspection readiness activities is an advantage.
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