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Senior Manager
PV Auditing and Lifecycle Management
Posted on 7/6/2022
Uxbridge, UK • Chicago, IL, USA
Experience Level
Desired Skills
Google Cloud Platform
  • Degree/Certification/Licensure University Graduate, Life Sciences or Quality related degree preferred - or equivalent combination of education, training, and experience
  • At least 4 years in PV auditing and/or 6 years of work experience in Clinical, Medical, Pharmacovigilance or Regulatory Quality
  • Demonstrated expertise and specific technical knowledge of clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs activities
  • Knowledge of global PV legislation and guidance, ICH/GCP, clinical research, medical affairs and regulatory processes and principles of Quality Assurance, including QRM and critical thinking
  • GVP wide range of auditing skills including audits at vendors, co-development/licensing partners and systems supporting PV and regulatory activities across the product lifecycle, as well as profound inspection coordination skills
  • Contribute to the maintenance of a risk-based audit strategy
  • Perform PV audits across the product lifecycle, including audits of business partners, vendors, REMS and internal systems to assess regulatory compliance, including planning, preparation, execution, reporting and FU on effectiveness of actions
  • Resolve audit findings
  • Partner with internal audit organization on the execution of GxP audits, and prioritize as determined through the risk-based audit strategy
  • Apply audit principles, procedures and methods and focus on matters of significance
  • Collect information through effective interviewing, listening, observing, and reviewing documentation, electronic records, and data
  • Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions
  • Prepare clearly-written, concise, accurate and evidence-based audit reports. Maintain records in the BMS QMS
  • Ensure CAPA are established within the specified timelines and address all aspects of the finding to prevent recurrence
  • Maintain an in-depth knowledge of worldwide regulations relating to clinical safety and pharmacovigilance
  • Support PV and GCP inspections, as assigned
  • Contribute to the quality management system relating to Clinical Safety/Pharmacovigilance, Regulatory and Medical Affairs activities, throughout the product lifecycle
  • Participate and support BMS Quality Management System initiatives, as assigned
  • Contribute to the management of critical and/or complex quality issues in the PV & LCM Quality remit
  • Advise on clinical safety/pharmacovigilance related matters
  • Establish strong partnership with business stakeholder
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.