| Urgent role || Risk Evaluation and Mitigation Strategy (REMS) - SME || Remote || Contract at Remote, Remote, USA |
| Email: [email protected] |
|
http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1033614&uid= From: Prashant Pal, Vbeyond Corporation [email protected] Reply to: [email protected] Hello , Greetings! This is Prashant from VBeyond Corp. We are a global recruitment company. One of our clients is looking Risk Evaluation and Mitigation Strategy (REMS) SME, Remote. Please share the profiles with linkedin url with Visa status for quick reply. Job Description: - Role:- Risk Evaluation and Mitigation Strategy (REMS) - SME Location : - Remote - EST Time Zone Duration:- Long Term (12+ months, possible extension) Type of role: - Contract Mandatory skill: Risk Evaluation and Mitigation Strategy (REMS), Description As a Risk Evaluation and Mitigation Strategy (REMS) SME, you should have: A deep appreciation of Drug safety, FDA REMS program requirements and key processes. Experience in setting up REMS program with exposure to multiple therapy areas Experience in regulatory submission standards and regulations Experience in design and implementation of REMS systems and tools. Strong foundations in drug safety and pharmacovigilance principles. Should have sound knowledge in Risk Evaluation and Mitigation Strategy (REMS), Periodic review reports, RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs) 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 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 Prior experience of participating in designing and implementing REMS systems Experience of implementing or using CRM systems such as Salesforce, Dynamics (highly advantageous) Experience working with Medical CRM In this role, you will Be a product owner and a domain lead for REMS implementation on a Salesforce platform. Engage with client stakeholders in refining and prioritizing product features and detailed workflows for REMS implementation. Lead a team of Business analysts and provide subject matter guidance through backlog grooming and product implementation Analyze requirements specified by FDA pertaining to REMS and other patient safety programs Design workflows, websites, information, reports, interfaces etc as required Document requirement specifications for the REMS system Act as a subject matter expert on REMS to various program participants especially the technology teams Perform validation of the system developed. This will include designing and executing test scenarios. 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. Lead the preparation and submission of expedited and periodic safety reports to health authorities, ensuring accuracy, completeness, and timeliness. Develop and implement risk management strategies, including REMS (Risk Evaluation and Mitigation Strategies) to minimize the potential safety risks. Reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies. Thanks Prashant https://www.linkedin.com/in/prashantpbh/ Keywords: http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1033614&uid= |
| [email protected] View All |
| 11:58 PM 19-Jan-24 |