Senior Manager Pharmacovigilance Auditing

Working with Us

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Position Purpose

Senior Manager Pharmacovigilance (PV) Audit is responsible for ensuring compliance with PV regulations and guidelines.

This involves conducting audits of PV systems processes and third parties to ensure the safety and efficacy of Bristol Myers Squibb's pharmaceutical marketed products.

Key Responsibilities

• Lead and coordinate internal and external pharmacovigilance audits of the BMS PV System and its Quality System.
• Audit types will include Critical processes Affiliates Licensing Partners Service Providers/Vendors Distributors and NI PASS).
• Document audit findings and prepare detailed audit reports in line with procedural timelines.
• Escalate concerns and provide expert guidance on PV compliance issues
• Support and advise on the development of appropriate corrective and preventive actions.
• Proactively manage findings responses and CAPA arising from audits in the BMS Quality Management system.
• Review the effectiveness of actions to address audit findings
• Provide input in the global audit plans based on identified signals/trends/risks/gaps
• Maintain expertise in countryspecific and global PV regulations and guidelines.
• Serve as a subject matter expert on PV related topics and advise on regulatory clinical safety/ pharmacovigilance related matters
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems
• Support inspection activities (i.e. mock interviews document review back room support)
  
  

Required Qualifications

• University Graduate in Pharmacy Medicine or Life Sciences or equivalent experience.
  
  

Required Experience & Competences

• Experience in Pharmacovigilance Regulatory Affairs and/or Clinical Safety.
• Proven problemsolving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
• Proficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with data.
• Responds resourcefully to changing business conditions and opportunities proactively looking for ways the organization can adapt its plans tactics or strategies.
  
  

Required Knowledge

• Demonstrated expertise of clinical safety and pharmacovigilance and/or regulatory affairs.
• Demonstrated knowledge of global PV legislation and guidance and principles of Quality Assurance.
• Analytical organizational and planning skills.
  
  

Ideal candidates will have

• Quality Assurance/Compliance and PV Auditing experience preferred or equivalent combination of education training and experience in Pharmacovigilance.
• Communicates professionally clearly concisely and consistently both verbally and in writing to internal and external customers
  
  

If you come across a role that intrigues you but doesn't perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work Lifechanging Careers

With a single vision as inspiring as Transforming patients' lives through science™ every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture promoting diversity in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

Onsite Protocol

Responsibilities

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For fieldbased and remotebydesign roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit careers.bms.com/ eeo accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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Bristol Myers Squibb is Disability Confident Employer

A UK Government scheme