Pharmacovigilance & QA
Job Description:
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:
- 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.
- 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)
Required Skills:
GMP Thai Deviations Quality Management Regulatory Requirements Assurance Decision-Making Quality Assurance Risk Management Manufacturing Regulations Records Suppliers Documentation Sales Training Management