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    Global Risk Management Scientist - Hyderabad, India - Bristol Myers Squibb

    Bristol Myers Squibb
    Bristol Myers Squibb Hyderabad, India

    1 week ago

    Default job background
    OTHER
    Description
    Working with Us
    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: .

    BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

    Summary

    The Global Risk Management (GRM) Scientist reports to the GRM Therapeutic Area (TA) Lead(s) or designee (i.e. GRM TA Product Lead(s)).

    This critical role supports the GRM TA on the implementation of Risk Management Plans (RMPs), additional risk minimization measures (aRMMs) and additional pharmacovigilance activities (APVAs) required for assigned assets by 1) driving global and local implementation activities, 2) providing support for all local markets (LMs) and 3) consulting with GRM TA Product Lead on an ongoing basis. This role will also provide risk management (RM) strategic support for early development assets and/or marketed products as assigned by the GRM TA Lead(s) and have accountabilities for other key GRM TA related projects and processes. This role may support across TAs.

    This role is based in Hyderabad, Telangana, India.

    Responsibilities
    • In consultation with GRM TA Lead or designee, support the implementation and management of RMPs and related aRMMs/APVAs, as required:
    Support the management of RMP and related aRMMs/APVAs (e.g. global, regional and/or local commitments) implementation and associated LM and REMS collaborations, including but not limited to:

    Complex aRMMs (i.e., Pregnancy Prevention Programs, Controlled Distribution Programs, etc.).

    aRMM direct import (DI) activities (i.e., coordinate and monitor DI vendor website and associated alerts).

    Business agreement changes (in-licensing/Pharmacovigilance Agreements) that impact RM.

    Additional RM related activities include but not limited to:

    GRM related training management (i.e. planning/tracking/repository) in collaboration with PV Learning Strategy function.

    aRMM effectiveness related activities (i.e., manage data acquisition, etc.).

    Ongoing GRM TA Regulatory Information Management system (Verity) related tasks for RMPs and aRMMs, including process improvements (i.e., Verity User Guide/User Requirements and associated work instructions).

    Track budget spend and monitor vendor key performance indicators, as needed.

    Maintenance, tracking and support repository of all materials and queries related to above.
    • Support GRM TA Lead with RM related Non-Interventional Research (NIR) activities (global and/or local).
    • Support GRM TA Lead in managing, collating, and access of LM RMP related queries from Local Health Authorities (HAs).
    • Support other innovative projects to further RM related intelligence and efficiencies (i.e. HA RM related queries and other RM initiatives such as functional endorsed AI tools/platforms, new collaborative methods, etc.).
    • Maintain inspection readiness and participate in audits and inspections related to GRM.
    • Support GRM TA processes and procedures working in conjunction with GRM TA, GPO/GPL (as required).
    • Support the development and maintenance of RM-related SOPs, WIs, metrics, quality checks in close collaboration with GPO/GPL and GRM SOE.
    • Maintains a thorough understanding of RM regulations and industry trends.
    • Other responsibilities as assigned by GRM TA Lead.
    Requirements:
    • Advanced scientific degree preferred
    • More than 3 years of relevant pharmaceutical industry experience
    • Experience in global pharmaceutical safety risk management is preferred
    • Understanding of pharmacovigilance/regulatory environment is expected
    Skills/Knowledge Required:
    • Proven ability to foster partnerships across companies and organizational boundaries
    • Demonstrated ability working in cross-functional teams, and driving decisions that involve multiple constituencies and constraints
    • Excellent listening and analytical skills, along with excellent written, verbal and interpersonal communication skills
    • Excellent time management skills and demonstrated ability to provide flexibility with support according to asset workloads
    • Advanced user of Microsoft Office tools
    #HYDDD #LI-Hybrid

    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 scienceTM , 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 . Visit 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.
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