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 TitleSenior Specialist, 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, 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 / ObjectiveParticipates in and supports multi-functional teams in the timely development of high quality Pharmacovigilance Agreements (PVAs) to support BMS License Contracts and Clinical Studies.Position Responsibilities

• Has a general understanding, and stays abreast of, current and evolving Regulatory guidelines related to safety reporting for key international business regions, and actively applies such learnings to PVA-related activities
• Manages the categorization and storage of license contracts, manages sensitive and confidential information
• Builds and maintains strong relationships with other BMS functional areas to complete and facilitate implementation of PVAs and ensure compliance with pharmacovigilance requirements
• Serves as a liaison between WWPS headquarters and international BMS business offices (e.g. PV affiliates) to support the maintenance of PVAs
• Participates in the coordination and maintenance of licensing data collection and tracking systems for business agreements and PVAs and verifying PVA responsibilities with appropriate colleagues in WWPS
• 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
• Supports the thorough and accurate analysis of data, gathers critical information, and supports the delivery of quality solutions to critical business tasks
• Works with manager to evaluate resource needs

Degree RequirementsMinimum B.S. Degree (or equivalent) in a relevant scientific field, such as pharmacy, nursing, or other life sciencesExperience Requirements

• At least 2-5 years of relevant experience in regulatory, safety, licensing, or clinical research function with a pharmaceutical company
• Ability to participate in and support multifunctional teams and act as representative in meetings within BMS/WWPS
• 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

• Good working knowledge of the drug development process, regulatory guidelines (e.g. FDA, ICH, etc.) relating to pharmacovigilance, and Good Clinical Practices Micro suite
• SharePoint
• Applications as required by department/position
• 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