Senior Quality Assurance Specialist

1 month ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time
Job Summary

We are seeking a highly skilled and experienced Quality and Compliance Specialist 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.
  • Conduct 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 with key stakeholders and vendors regarding performance metrics and contractual and regulatory requirements.
  • 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.
  • Strong scientific background in a life science related field.
  • Prior quality-related experience in pharmacovigilance 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: Experienced in advanced functionalities of operational tools.
    • Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods.
    • Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements.
  • Analytical Skills:
    • Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data.
    • Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments.
    • Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality.
  • Strategic Skills:
    • Strategic Thinking: Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies.
    • Decision-Making: Uses data summaries to support decisions based on clearly defined options and guidelines.
    • Change Management: Supports digital change initiatives and communicates their immediate benefits.
What We Offer

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We offer a unique and inclusive culture that promotes diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

We care about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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