Global Risk Management Scientist
Bristol-Myers Squibb
Full time- 3+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 04, 2024
- End Date: Jun 04, 2024
- 3+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 04, 2024
- End Date: Jun 04, 2024
Skills:
- pharma
- pharmacovigilance
- Management
Job Description:
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.
Qualification & Experience
- 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
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Salary
Not Disclosed
-
Role
Scientist
-
Area of Practice
- Pharmacology/ Pharmacovigilance
-
Experience
3+ years
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