Job Title: Senior Manager, Pharmacovigilance (PV) Auditing
Location: Remote – United Kingdom, Switzerland, +2 more locations
Department: Pharmacovigilance Quality Assurance
Reports To: Director, Pharmacovigilance Auditing
Job Summary
The Senior Manager, Pharmacovigilance (PV) Auditing is responsible for ensuring compliance with global PV regulations by conducting audits of PV systems, processes, and third-party partners. The role ensures the safety and efficacy of Bristol Myers Squibb’s marketed pharmaceutical products through rigorous quality assurance practices.
Key Responsibilities
1. Audit & Compliance Oversight
Lead and coordinate internal and external pharmacovigilance audits covering:
Critical PV processes
Affiliates
Licensing partners
Service providers/vendors
Distributors
Non-Interventional Post-Authorization Safety Studies (NI PASS)
Document audit findings and prepare detailed audit reports within procedural timelines.
Provide expert guidance on PV compliance issues and escalate concerns as needed.
Develop and oversee corrective and preventive action plans (CAPA) in response to audit findings.
Monitor and review the effectiveness of CAPA implementation in BMS Quality Management Systems.
Contribute to global audit planning by analyzing signals, trends, risks, and compliance gaps.
2. Regulatory & Industry Standards Compliance
Maintain up-to-date knowledge of global and country-specific PV regulations and guidelines.
Act as a subject matter expert (SME) on PV compliance, advising internal teams on regulatory, clinical safety, and pharmacovigilance matters.
Ensure compliance with ICH, FDA, EMA, MHRA, and other global health authority requirements.
3. Inspection & Quality Assurance Support
Provide support for regulatory inspections, including:
Mock interviews
Document review
Backroom support during inspections
Actively share knowledge across departments and functional lines through knowledge-sharing processes and systems.
Qualifications & Experience
Education:
Bachelor’s Degree or higher in Pharmacy, Medicine, Life Sciences, or a related field.
Experience & Competencies:
Experience in Pharmacovigilance (PV), Regulatory Affairs, or Clinical Safety is required.
Prior Quality Assurance, Compliance, or PV Auditing experience is preferred.
Strong problem-solving skills to navigate complex process and quality-related challenges.
Proficiency in data analysis to identify risks, trends, and insights for audit planning.
Ability to adapt to changing business conditions and proactively improve processes.
Technical & Soft Skills:
Strong knowledge of clinical safety, pharmacovigilance, and regulatory affairs.
Familiarity with global PV legislation and guidelines.
Excellent analytical, organizational, and planning skills.
Effective communication skills, both written and verbal, with internal and external stakeholders.
Compensation & Benefits
Competitive salary & incentives (based on experience and location).
Comprehensive benefits package, including healthcare, retirement plans, and work-life balance programs.
Opportunities for career growth and professional development.
Work Environment & Travel
Remote work flexibility with occasional travel as needed.
Some travel may be required for onsite audits, regulatory inspections, and industry conferences.
Why Join Bristol Myers Squibb?
BMS offers an opportunity to work in a challenging, meaningful, and innovative environment, where you can contribute to life-changing scientific advancements. Join a diverse team dedicated to transforming patients’ lives through science.
Apply today and make an impact!
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