Global Risk Management Scientist

3+ years

Not Disclosed

Hyderabad

10 June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words 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 achieving breakthroughs in cell therapy, this work transforms the lives of patients and the careers of those who do it. You’ll have 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.

BMS Hyderabad is an integrated global hub focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center supports a range of technology and drug development activities, helping 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 in implementing Risk Management Plans (RMPs), additional risk minimization measures (aRMMs), and additional pharmacovigilance activities (APVAs) required for assigned assets by:

Driving global and local implementation activities.
Providing support for all local markets (LMs).
Consulting with the GRM TA Product Lead on an ongoing basis.

This role also provides risk management (RM) strategic support for early development assets and/or marketed products as assigned by the GRM TA Lead(s) and is accountable for other key GRM TA-related projects and processes. This role may support across TAs and is based in Hyderabad, Telangana, India.

Responsibilities

Support the implementation and management of RMPs and related aRMMs/APVAs in consultation with GRM TA Lead or designee.
Manage RMP and related aRMMs/APVAs implementation and associated LM and REMS collaborations.
Handle complex aRMMs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs).
Coordinate and monitor aRMM direct import (DI) activities, including DI vendor website and associated alerts.
Manage business agreement changes impacting RM.
Oversee GRM-related training management in collaboration with PV Learning Strategy function.
Conduct aRMM effectiveness activities, including managing data acquisition.
Manage ongoing GRM TA Regulatory Information Management system (Verity) related tasks.
Track budget spend and monitor vendor key performance indicators.
Maintain, track, and support the repository of all materials and queries related to the above activities.
Support GRM TA Lead with RM-related Non-Interventional Research (NIR) activities.
Manage, collate, and access LM RMP-related queries from Local Health Authorities.
Support innovative projects to enhance RM-related intelligence and efficiencies.
Maintain inspection readiness and participate in audits and inspections related to GRM.
Develop and maintain RM-related SOPs, WIs, metrics, and quality checks in collaboration with GPO/GPL and GRM SOE.
Stay updated with RM regulations and industry trends.
Other responsibilities as assigned by the GRM TA Lead.

Requirements

Advanced scientific degree preferred.
More than 3 years of relevant pharmaceutical industry experience.
Experience in global pharmaceutical safety risk management preferred.
Understanding of pharmacovigilance/regulatory environment expected.

Skills/Knowledge Required

Proven ability to foster partnerships across companies and organizational boundaries.
Demonstrated ability to work in cross-functional teams and drive decisions involving multiple constituencies and constraints.
Excellent listening, analytical, written, verbal, and interpersonal communication skills.
Excellent time management skills and flexibility to support varying asset workloads.
Advanced proficiency with Microsoft Office tools.

Additional Information

If you come across a role that intrigues you but doesn’t perfectly align 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 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. 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 employees are required to work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type assigned is determined by the role’s nature and responsibilities:

Site-essential roles require 100% onsite presence.
Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite presence.
Field-based and remote-by-design roles require physical travel to visit customers, patients, or business partners and attend meetings.

BMS is committed to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. Applicants can request accommodations during the recruitment process. For accommodations, direct inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.

BMS cares about 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 stay updated with Covid-19 boosters.

BMS will consider qualified applicants with arrest and conviction records for employment, pursuant to applicable laws.

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