Global Risk Management Scientist
6 months ago
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.
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
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