Job Description
Organisation: Bristol Myers Squibb (BMS)
Location: [Insert location / remote / hybrid details]
Occupancy Type: [Site-essential / Site-by-design / Field-based / Remote-by-design]
Salary: Competitive, with comprehensive benefits
Contract Type: [Permanent / Fixed-term]
Closing Date: [Insert if applicable]
About Bristol Myers Squibb
At Bristol Myers Squibb, you’ll find work that is challenging, meaningful, and life-changing. From advancing breakthroughs in cell therapy to improving patient safety, everything we do transforms lives – both for patients and for our employees.
We are committed to supporting career growth, flexibility, and well-being, offering competitive benefits and development opportunities. Learn more at: careers.bms.com/working-with-us.
Role Purpose
To collaborate with Patient Safety (PS) Global Process Leads (GPL) and Global Process Owners (GPO) to develop and implement a quality and compliance framework, ensuring regulatory adherence, continuous monitoring, and risk mitigation within pharmacovigilance processes.
Key Responsibilities
Quality & Compliance Monitoring: Develop and execute monitoring activities to support a robust GVP Quality Management System.
Data Analysis: Collect and analyse data from multiple sources (GPLs, GPOs, PV Compliance, QRM team) to identify trends, risks, and opportunities.
Reporting & Visualisation: Prepare and present reports using tools such as Tableau or Power BI, translating complex datasets into actionable insights.
Collaboration: Work with SMEs, functional leads, and the Head of PV Process Excellence to reinforce quality and compliance practices.
Strategy Evaluation: Assess effectiveness of quality management programmes and recommend strategic improvements.
Stakeholder Management: Communicate with key PS stakeholders, review performance metrics, and escalate compliance risks where necessary.
Process Improvement: Identify and drive opportunities to enhance PS processes in partnership with global leads.
Audits & Inspections: Support inspections/audits and implement feedback for continuous improvement.
Tools & Intelligence: Define business requirements for IT and collaborate on analytical/technical solutions to support PV systems health monitoring.
Key Competencies
Critical Thinking: Ability to evaluate evidence and make reasoned judgments.
Data Management: Skilled at identifying anomalies, patterns, and trends.
Strategic Thinking: Understanding of digital tools in operational efficiency.
Decision-Making: Data-driven approach to problem solving and compliance.
Qualifications & Experience
Degree in Life Sciences, Pharmacy, Nursing or related field (B.S.N./RN, B.A./B.S./M.S., Pharm.D. or equivalent).
Minimum 8 years of pharmaceutical industry experience, including pharmacovigilance, drug development, clinical development, or regulatory affairs.
Extensive knowledge of global pharmacovigilance regulations.
Strong data analysis and reporting skills with proficiency in Tableau, Power BI, AI/ML tools.
Prior experience in pharmacovigilance quality and compliance (preferred).
Proven ability to advise senior management on regulatory and compliance matters.
Experience negotiating complex compliance issues.
Strong communication and collaboration skills in a complex, evolving environment.
Why Join Us
Work on uniquely interesting projects with global impact.
Be part of a culture built on passion, innovation, urgency, accountability, inclusion, and integrity.
Access to professional growth, flexibility, and a supportive environment.
Additional Information
On-site protocol: Role occupancy type determined by responsibilities (site-essential, hybrid, field-based, remote).
Inclusion & Accessibility: BMS provides reasonable workplace adjustments and supports applicants with disabilities throughout the recruitment process.
Well-being: BMS strongly recommends Covid-19 vaccination and boosters for all employees.
Equal Opportunities: BMS is an equal opportunity employer and a Disability Confident – Employer under the UK Government scheme.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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Warsaw |