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Challenging. Meaningful. Life-changing. Those aren't 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'll 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: careers.bms.com/working-with-us .

Division

Research and Development / Global Drug Development /

Worldwide Patient Safety/ Safety Evidence and Sciences/ Submissions and Operational Excellence

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines through 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

The Pharmacovigilance (PV) Associate I will support administrative and operational activities for Signal Detection (SD), Safety Data Review (SDR) and Scheduled Aggregate Reports (SARs), Safety Management Team (SMT) system set-up, access support, data coordination, and tracking of actions.

Position Responsibilities

Apply medical, life science and general scientific knowledge and expertise to effectively support the following:

Signal Detection/Safety Data Review

Signal Detection Support

• Generate and file data for signal detection and safety data review

• Execute literature searches and retrieve and deliver full-text articles

• Safety Data Review Meeting (SDRMs) support and logistics

Signal Documentation and Notifications

• Generates reports and upload into Signal Tracker

• Quality Check (QC)

Safety Management Team

• Create and manage SMT Membership List

• Create and manage SMT Mail Group

• Create and manage SMT File Share (i.e., Safety Data Review Folder)

• Create and manage associate systems (i.e., Sharepoint [SP] site, Document Management System)

• Schedule routine meetings

• Manage asset close out

• Manage MSAPSMT mailbox/meeting calendar

• Manage access, permissions and content related to SMT OneSafe and SharePoint Online for assigned assets.

Scheduled Aggregate Report

• Obtain Exposure data and update document

• Generate and file supporting data

• Support literature searches and deliver full-text articles

Document Compliance, Management, Support

• Transferring data into reports

• Formatting

• Querying follow up

• Closing, filing, tracking

Other Activities

• Manage data received in PV mailbox

• Update signal detection lists (e.g., Monitored events, Literature search terms, etc.) related MedDRA upgrades

Degree Requirements

BS/RN/MS/PharmD in life sciences or equivalent relevant scientific qualifications or professional training.

Experience Requirements

Must have requirements:

• Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.

• Minimum of 2 years professional experience in health science or relevant life sciences/medical fields, or appropriate pharmaceutical industry or academic experience

• Demonstrated understanding of global pharmaceutical drug development and lifecycles.

Ideal Candidates Would Also Have:

• Demonstrated excellence in scientific technical skills with a comprehensive understanding of pharmacovigilance processes.

• Extensive experience in the organization, coordination, and communication of data and information.

• Project or program management experience and/or qualifications.

• Experience in working with diverse teams.

Key Competency Requirements

• Working understanding of pharmacovigilance activities/processes and medical concepts.

• Working understanding of team priorities and milestones.

• Ability to manage timelines and quality of work using organizational and interpersonal communication skills.

• Good collaborative and communication skills.

• Attention to detail with scientific, analytical and conceptual skills and the ability to reach reasoned conclusions.

Operational Skills:

• Technical Proficiency: Basic use of standard operational software and tools for automation.

• Process Management: Understanding of current processes and ability to evaluate and suggest digital improvements.

• Problem-Solving: Addresses straightforward problems with simple digital solutions.

Analytical Skills:

• Data Management: Processes and records data and information in structured computer readable formats

• Critical Thinking: Identifies flaws and inconsistencies in data or business processes by considering the system wide impact

• Data Analysis: Can perform basic data gathering and reporting using standard tools.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1582629

Updated: 2024-06-28 03:18:57.765 UTC

Location: Hyderabad-IN

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.