Pharmaco Vigilance QA Specialist
Ensure quality and compliance in drug safety operations.
HealthcareBengaluru, India3+ yearsFull-time
About this role
We're seeking an experienced Pharmaco Vigilance QA Specialist to ensure quality and compliance in our drug safety operations. The ideal candidate will have strong expertise in pharmacovigilance processes, regulatory compliance, and quality assurance activities.
Ensure quality and compliance in drug safety operations.
Key Responsibilities
- Conduct quality assurance reviews of pharmacovigilance processes and documentation
- Perform audits of adverse event reports, case processing, and safety databases
- Ensure compliance with global pharmacovigilance regulations and guidelines
- Review and validate safety data entry and case narratives for accuracy
- Develop and maintain quality assurance procedures and standard operating procedures
- Identify areas for improvement and implement corrective and preventive actions
- Collaborate with cross-functional teams to ensure quality standards are met
- Prepare quality reports and documentation for regulatory submissions
Requirements & Qualifications
Required Qualifications
- 3+ years of experience in pharmacovigilance or drug safety quality assurance
- Strong knowledge of global pharmacovigilance regulations (FDA, EMA, ICH guidelines)
- Experience with adverse event reporting and safety database management
- Understanding of medical terminology and drug safety principles
- Proficiency in pharmacovigilance software and quality management systems
- Excellent analytical, problem-solving, and documentation skills
- Strong attention to detail and ability to work in a regulated environment
- Bachelor's degree in Pharmacy, Life Sciences, or related field
Required Skills & Technologies
PharmacovigilanceDrug SafetyQuality AssuranceRegulatory ComplianceAdverse Event ReportingMedical Terminology