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Senior Manager, Pv Quality Compliance Lead

0-2 years
Not Disclosed
10 Sept. 16, 2025
Job Description
Job Type: Remote Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.