Pharmaco Vigilance QA Specialist
Ensure quality and compliance in drug safety operations.
What You'll Do
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.
Your Impact
Here's what you'll be responsible for in this role
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
What We're Looking For
- 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
What We Offer
We believe in taking care of our team members
Apply for This Position
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