Clinical Data Quality Specialist, PV In-line Review
6 days ago
We are seeking a highly skilled Clinical Data Quality Specialist to join our Patient Safety team at Bristol Myers Squibb. This is an exciting opportunity for individuals who are passionate about ensuring the quality and integrity of clinical data.
Job SummaryThe Clinical Data Quality Specialist will be responsible for conducting in-line quality reviews of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements and company conventions. The successful candidate will have a strong understanding of medical concepts, biology, and chemistry, as well as excellent attention to detail and analytical skills.
Key Responsibilities:- Conduct in-line quality reviews of ICSR's to ensure accuracy, completeness, and compliance with regulatory requirements and company conventions.
- Identify and escalate any discrepancies and quality issues observed during the review process.
- Provide guidance and support to the case processing team on quality related matters.
- Collaborate with cross-functional teams, including PV Compliance & Quality, Medical Safety Review, Case Processing Vendor, to ensure alignment on safety-related activities.
- Develop and maintain quality metrics and reports to track performance and identify areas for improvement.
- Bachelor's degree in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy; advanced degree preferred.
- A minimum of 5-7 years of experience with processing of adverse events in safety or clinical settings, with a focus on ICSR quality.
- Thorough understanding of Regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.
- Knowledge of international ICSR processing and reporting requirements, regulations, guidelines, and procedures.
Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming patients' lives through science. Our mission is to discover, develop, and deliver innovative medicines that help patients achieve better health outcomes. We value diversity, inclusion, and collaboration, and we are dedicated to creating a work environment that supports the success of our employees.
Compensation and BenefitsThe salary for this position is estimated to be around $110,000 per year, based on industry standards and location. In addition to a competitive salary, we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We also provide opportunities for professional development and growth, as well as a dynamic and inclusive work environment.
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