Quality Assurance Specialist, Pharmacovigilance

4 weeks ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

Job Summary

We are seeking a highly skilled Quality Assurance Specialist, Pharmacovigilance to join our team at Bristol Myers Squibb. The successful candidate will be responsible for ensuring the quality and compliance of our pharmacovigilance activities, including safety database case processing, quality monitoring, and compliance with global regulatory requirements.

Key Responsibilities

  • Perform ongoing monitoring of end-to-end case processing related activities in the global safety database.
  • Perform quality and compliance monitoring activities with respect to safety signals, key medical safety information, and other relevant areas of pharmacovigilance.
  • Collaborate with local and global Quality oversight leads, Case Management and Medical Review Teams for continuous quality improvement.
  • Communicate suggestions on revising quality monitoring strategies and programs based on results, business risk, external and/or internal feedback.
  • Ensure effective communication to local Quality oversight lead regarding identified risks and recommendations for potential improvement of quality.
  • Execute quality monitoring activities associated with measure of effectiveness of health authority, audit, or Deviation CAPA implementation.
  • Ensure effective communication with key WWPS stakeholders and vendors to include review of their performance metrics.
  • Escalate any suspected compliance, quality concerns or potential risks associated with in-house or outsourced Pharmacovigilance activities to management.

Requirements

  • A minimum of 5 years pharmaceutical industry experience, including 3 years of pharmacovigilance, drug development, clinical development or regulatory affairs experience specifically involving Safety Database case processing.
  • Prior experience in IT project management, including skills for JIRA management, HP ALM, and SharePoint management is preferred.
  • Strong scientific background in a life science related field.
  • Prior quality-related experience in pharmacovigilance is preferred.
  • Successful and creative negotiation of difficult compliance issues.
  • Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.

Competencies

  • Operational Skills: Technical Proficiency, Problem-Solving, Process Management.
  • Analytical Skills: Data Analysis, Critical Thinking, Data Management.
  • Strategic Skills: Strategic Thinking, Decision-Making, Change Management.

About Us

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to delivering innovative medicines and therapies that improve the lives of patients with serious diseases. Our team is passionate about making a difference and is driven by a shared vision to transform patients' lives through science.

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