Ensure compliance of clinical development activities and pharmacovigilance system with regulatory requirements, internal procedures, and quality standards
Job Summary
Ensure compliance of clinical development activities and pharmacovigilance system with regulatory requirements, internal procedures, and quality standards.
Independently plan, conduct, report, and follow up on audits related to Clinical Operations and Pharmacovigilance activities to verify compliance and contribute to continuous improvement.
Operate within a global, cross-functional environment, working closely with internal departments and external stakeholders to identify compliance risks and promote a strong quality culture.
Matching Summary
Ensure compliance of clinical development activities and pharmacovigilance system with regulatory requirements, internal procedures, and quality standards.
Skills & Requirements
Must-have
GCP and GVP audits
Clinical Operations auditing
Pharmacovigilance auditing
GxP standards and regulatory requirements
Computerized system validation principles
Veeva Vault Quality Suite experience
Nice-to-have
Strong conflict-resolution skills
Diplomatic approach
Resilience under pressure
Proactive problem identification
Positive attitude and enthusiasm
Key Requirements
Minimum 5 years of experience in QA, Clinical Operations, Pharmacovigilance, or auditing