Pharmacovigilance Auditor
Company: Rosaires Care
- Location: Bridgeport, United States
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Role Summary
Perform global pharmacovigilance audits of external vendors and internal safety functions to evaluate the accuracy of safety data and adherence to applicable regulations and corporate standards.
Key Responsibilities
- Conduct audits covering pharmacovigilance processes, safety data quality, and regulatory/compliance expectations.
- Categorize and document audit findings with clear evidence and impact assessments.
- Recommend corrective and preventive actions to address gaps and strengthen compliance.
- Identify recurring trends, emerging risks, and opportunities to improve drug safety systems.
- Support continuous improvement of audit methodologies, procedures, and overall pharmacovigilance quality practices.
Qualifications & Skills
- Strong knowledge of pharmacovigilance principles, drug safety data handling, and quality/compliance requirements.
- Proficiency in audit planning, execution, and reporting with rigorous documentation standards.
- Analytical skills to recognize patterns, assess risk, and propose practical improvements.
- Ability to drive corrective/preventive actions and contribute to process enhancements.
