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Open nowFirst seen 13 hours ago

Pharmacovigilance & QA

People Profilers1,158 open roles

Where
Bangkok, Bangkok, Thailand
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Your applicationOpen nowPharmacovigilance & QAPeople Profilers · Bangkok, Bangkok, Thailand

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The clock on this job

Early applications get read.

11.5% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.0%1 day
  2. 4.3%3 days
  3. 11.5%7 days
  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: first seen 13 hours ago

The posting

A highly motivated and detail-oriented Pharmacovigilance (PV) and Quality Assurance (QA) Specialist with experience in the pharmaceutical industry. The role involves ensuring compliance with regulatory standards, managing quality assurance processes, and overseeing pharmacovigilance activities. A thorough understanding of PV and QA principles is required.

Key Responsibilities:

  1. Pharmacovigilance: Monitor and evaluate adverse drug reactions (ADRs) and other safety data to ensure product safety. Prepare and submit safety reports (e.g., PSURs, DSURs) to regulatory authorities and coordinate with suppliers. Maintain and update the Risk Management Plan (RMP) for medicines and medical devices. Ensure compliance with local and international PV regulations. Conduct PV audits and inspections to mitigate risks before/after a case occurs. Collaborate with clinical, regulatory, and medical affairs teams to support safety-related activities. Provide training to staff on adverse event reporting and compliance with GDP standards.
  2. Quality Assurance: Develop, implement, and maintain quality management systems (QMS) to meet regulatory requirements. Conduct internal audits and inspections to ensure compliance with GMP, GCP, GLP, and GDP. Review and approve SOPs, batch records, and quality documentation for commercial batches. Manage deviations, change controls, and CAPA processes. Collaborate with cross-functional teams to ensure quality standards throughout the product lifecycle. Provide training on quality-related topics and best practices. Regularly review and update quality control processes and documents to comply with regulatory announcements. Support GDP approval requests and coordinate with relevant departments for smooth operation. Review pharmaceutical quality documents, such as Certificates of Analysis (COA), and assist with translations and coordination with logistics. Maintain records to ensure compliance and product release certification.

Qualifications:

  • Bachelors degree in Pharmaceutical Sciences or a related field (advanced degree preferred).
  • 1-3 years of experience in quality assurance and pharmacovigilance.
  • Knowledge of GMP, GCP, GLP, GDP, and PV regulations (e.g., FDA, EMA, ICH)
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