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:

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)