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Position Summary

The Associate Director of PV Audits is responsible for ensuring compliance with pharmacovigilance (PV) regulations and guidelines. This role involves conducting audits of PV systems, processes, and third parties to ensure the safety and efficacy of BMS’ pharmaceutical marketed products.

Key Responsibilities:

Lead and coordinate internal and external pharmacovigilance audits of the BMS PV System and its Quality System (including Critical processes, Affiliates, Licensing Partners, Service Providers/Vendors, Distributors, and NI PASS) to ensure compliance with regulatory requirements, company procedures and contractual arrangements.

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;

Conduct risk assessments for specific audit types in line with regulatory requirements and expectations (as applicable).

Provide input in the global audit plans based on identified signals/trends/risks/gaps;

Provide training on pharmacovigilance regulations and guidelines to internal teams and external partners as needed.

Maintain expertise in country-specific and global PV regulations and guidelines.

Develop, deliver and support training needs for junior auditors

Serve as a subject matter expert on PV related topics and advise on regulatory, clinical safety/ pharmacovigilance related matters;

Establish strong partnership with business stakeholders.

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, hosting, as required.

Qualifications & Experience:

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

Extensive experience in Pharmacovigilance/Regulatory Affairs/Clinical Safety/Medical Affairs.

Quality Assurance/Compliance and PV Auditing experience preferred or equivalent combination of education, training and experience in Pharmacovigilance.

Demonstrated expertise and specific technical knowledge of clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs activities of at least 8 years in the pharmaceutical industry or equivalent.

Minimum of 5 years in Clinical, Medical, Pharmacovigilance or Regulatory Quality.

Demonstrated strong knowledge of global PV legislation and guidance, medical affairs and regulatory processes and principles of Quality Assurance.

Demonstrated applied knowledge of pre-and post-marketing regulatory requirements,

Analytical, organizational and planning skills.

Broad knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.

Proven problem-solving 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.

Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.

Ability to manage projects and deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.

#LI-Remote

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, Life-changing 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.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design 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 field-based and remote-by-design 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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