Safety Reconciliation Manager

1 week ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

Bristol Myers Squibb is a leading biopharmaceutical company that is dedicated to transforming patients' lives through science.

We are seeking an experienced Safety Reconciliation Manager to join our team in the Worldwide Patient Safety group. As a key member of our team, you will be responsible for ensuring the quality and accuracy of adverse event reports and navigating the intricacies of the BMS Drug Safety Databases to process adverse event reports.

**Job Summary:**

  • This is a global role that supports the Worldwide Patient Safety Vision through understanding the impact of daily Safety Data Processing work on all stakeholders.
  • You will provide oversight of quality and process optimization through a Business Partner Model working with multiple global stakeholders across WWPS and external functions to ensure business critical safety data processing to support regulatory obligations.

**Key Responsibilities:**

  • Ensure the quality and accuracy of adverse event reports.
  • Navigate the intricacies of the BMS Drug Safety Databases to process adverse event reports.
  • Conduct comparisons of adverse event source documents against Safety Database screens for transcription and medical accuracy.
  • Demonstrate the ability to handle ambiguity of inquiries by identifying reporting regulations to provide solutions for resolution and escalate issues in contract agreements to senior management as appropriate.
  • Participate in review, update and execution of study/vendor specific related documents including but not limited to safety management plan (SMP), Pharmacovigilance Agreement (PVA) and Safety Data Exchange Agreements (SDEA).
  • Act as SME in Safety database configurational matters.
  • Assist with CRO, vendor oversight activities.
  • Assist with inspection readiness activities related to areas of focus.
  • Employ effective oral and written communication skills with multiple global stakeholders across WWPS and external stakeholders.

**Requirements:**

  • Bachelor's degree, Scientific/medical background (B.S./B.A) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy preferred.
  • Minimum of 3-5 years pharmaceutical experience preferred.

**Competencies:**

  • Knowledge of general, including international, ICSR processing and reporting requirements, regulations, guidelines and procedures.
  • Mastery of health / life sciences gained through either formal education or on job experiences.
  • Mastery of safety data processing, as well as the ability to understand the future impact.
  • Demonstrated ability to analyze and interpret complex problems/data gathered from a variety of sources and, through effective decision-making and planning, delivers superior business solutions.

**Estimated Salary Range:** $80,000 - $120,000 per year, depending on location and experience.

About Bristol Myers Squibb:

We offer a unique opportunity to work in a dynamic and innovative environment with a talented team of professionals who are passionate about making a difference in patients' lives. Our commitment to diversity, equity, and inclusion drives our approach to hiring, developing, and retaining top talent.

We are proud to be an equal opportunities employer and welcome applications from diverse candidates. We also offer a range of benefits, including comprehensive health insurance, retirement plans, and paid time off.

If you are a motivated and experienced professional looking for a new challenge, please submit your application today.

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