Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You\xe2\x80\x99ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .Job TitleAssociate Director, External AffairsDivisionResearch and Development / Global Regulatory, Safety and Biometrics / Worldwide Patient Safety/External AffairsFunctional Area DescriptionThe Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, External Affairs and Pharmacovigilance Agreements (PVAs), contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveDrives processes and cultivates relationships that result in the timely development of high-quality PVAs to support BMS commercial licensing and clinical collaborations.Position Responsibilities

• Has a general understanding, and stays abreast of, current and evolving Regulatory guidelines related to safety reporting for business regions globally, and actively applies such learnings to PVA-related activities
• Reviews and negotiates complex language in assigned contracts, manages sensitive and confidential information, and advises WWPS colleagues on impact of changing regulations and other external influences on safety data contractual obligations
• Builds and maintains strong relationships with other BMS functional areas and business partner representatives to complete and facilitate the implementation of PVAs and ensure compliance with applicable pharmacovigilance requirements
• Serves as a liaison between WWPS headquarters and BMS Local Patient Safety business offices (e.g. PV affiliates) in support of the development of PVAs and related pharmacovigilance activities
• Participates in the coordination and maintenance of data collection and tracking systems associated with business agreements and PVAs, verifying PVA responsibilities with appropriate colleagues in WWPS
• Manages PVA documentation including but not limited to active & terminated agreements as well as PVA implementation notifications. Responsible for initiating PVA implementation checklists.
• Manages/oversees storage and maintenance of PVAs and PVA templates
• Identifies ways to improve productivity and quality standards for PVA-related deliverables and actively participates in efforts to remedy non-compliance situations
• Provides support for development of process flows and work practices to clarify PVA-related systems and procedures to ensure compliance with pharmacovigilance requirements

Version 1.0 Employee Job Profile -

• Conducts thorough and accurate analysis of data, gathers critical information,

effectively assesses (with manager) required team resources, and delivers quality solutions to critical business tasks

• Works with quality team to provide support and guidance on PVA related

audit/inspection issues. Provides subject matter expertise in related activities. Provides response on relevant CAPAsDegree RequirementsMinimum B.S. Degree (or equivalent, advanced degree or MBA preferred) in arelevant scientific field, such as pharmacy, nursing, or other life sciencesExperience Requirements

• At least 5-10 years of direct relevant experience in regulatory, safety, licensing, or clinical research function with a pharmaceutical company

• Ability to participate in and/or lead multifunctional teams and act as representative in meetings between BMS and licensing partners
• Demonstrated ability to read and understand complex language in legal contracts, manage sensitive and confidential information, and analyze

complex problems/data

• Experience gathering, interpreting, and applying existing and emerging regulatory guidelines with implications for regulatory approval and drug

safety reporting

• Demonstrated ability to work with a range of technically and culturally diverse people to meet high quality requirements within tight timelines
• Strong organizational skills, ability to handle multiple projects, and effectively

communicate to diverse audiences at multiple levels within the company and through various formats (i.e. Presentations, written proposals/ reports/correspondence).Key Competency Requirements

• Strong working knowledge of the drug development process, regulatory guidelines (e.g. FDA, ICH, etc.) relating to pharmacovigilance, and Good Clinical Practices
• Microsoft Office suite
• SharePoint
• Familiarity with web-based systems (LEAD, E-time)

Travel RequiredOccasional travel for meetingsDescribe Exposure to Any Hazards/Disagreeable Conditions in the Work EnvironmentNone#HYDDD #LI-HybridIf you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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 ProtocolBMS 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 . Visit 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol-Myers Squibb