Responsibilities :
A deep appreciation of Drug safety, FDA REMS program requirements and key processes.
Develop and gather the material and guide the Purdue team for the future REMS Inspections.
Attend and actively participate on various REMS Consortium meetings and sub teams.
Knowledge and some experience in design and implementation of REMS systems and tools.
Strong foundations in drug safety and pharmacovigilance principles.
Knowledge of Stakeholder workflows including but not limited to EHRs, Pharmacy, REMS administrators, patients, and wholesalers.
Knowledge on current FDA regulations and guidance regarding REMS, including Medication Guides, ETASU, Shared REMS, Survey Methodologies, etc.
Should have awareness of changes to / new industry regulations Have knowledge of preparation of aggregate safety reports (e.
g., DSURs, Pharmacovigilance Plans,Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans (RMPs) Drug safety, pharmacovigilance and / or risk management industry experience in both the investigational and post-approval environments.
Knowledge and some experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI.
Deep understanding of global pharmacovigilance regulations, guidelines, and best practices.
Good understanding of SDLC requirements and 21 CFR Part 11, GxP guidelines.
Analyze requirements specified by FDA pertaining to REMS and other patient safety / risk management programs.
Document requirement specifications for the REMS system.
Act as a subject matter expert on REMS to various program participants especially the technology teams.
Coordinate with users of the REMS system to ensure that their needs are appropriately addressed through the system implementation.
Contribute to resolving any issues pertaining to implementation of REMS business requirements.
Provide regular updates to the project manager and highlight risks in a timely manner.
Facilitate internal review of REMS Assessment Reports and communicates the findings / observations back to REMS PMO.
Assist with the development and implementation of risk management strategies, including REMS (Risk Evaluation and Mitigation Strategies) to minimize the potential safety risks.
Review cumulative data with ability to interpret, synthesize and communicate complex clinical / pharmaceutical information.
Recommend enhancements to existing risk management / mitigation strategies and assist with the development of new risk management / mitigation strategies.
Requirements :
At least 5 years of experience in pharma (preferably drug safety, risk management, or epidemiology) with at least 2 years of direct experience in REMS.
Medical / scientific background, epidemiology preferred.
Experience in setting up REMS program with exposure to multiple therapy areas.
Experience investigating, documenting, and resolving instances of non-compliance by patients, prescribers, and pharmacies.
Experience collaborating with PMO and other RPC members of the consortium REMS on various topics.
Should have sound knowledge in Risk Evaluation and Mitigation Strategy (REMS), REMS Assessment reports, RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs).
FDA Regulation knowledge.
5 years of experience in pharma (preferably drug safety, risk management, or epidemiology) with at least 2 years of direct experience in REMS.
Must have experience in handling REMS audit.
Must have experience in direct REMS involvement.
Subject matter expert on REMS.
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