Subject Matter Expert
4 weeks ago
About our client:
Our client brings together Pharmacovigilance expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets.
Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets.
Requirements JOB DESCRIPTION
- Experience: 12-18 Years
- Location: East Coast, United States
- Employment : Full Time
- Should be excellent functional knowledge of PV Safety Systems like Oracle Argus Safety, Lifesphere Multivigilance etc.
- Should have experience in installing/ configuration/ validation of PV Safety Systems like Oracle Argus Safety, Lifesphere Multivigilance etc.
- Should attend all meetings as a PV Systems subject matter expert (SME).
- Should participate in and contribute to safety system design requirement specifications for the safety database as a PV Systems SME.
- Should provide vendor/client oversight of report development: Compliance, Aggregate, Signal Detection, Data Mining, Key Performance Indicators (KPIs).
- Should be able to review and provide feedback on templates (including team member training) on Tenant Configuration, Business Configurations, Code List changes, and User Permissions.
- Should be able to review and provide feedback on work instructions associated with ongoing safety database maintenance projects, including upgrades, Medical Dictionary for Regulatory Activities (MedDRA) / WHO Drug versioning, direct Electronic Submission Gateway (ESG) setup, etc.
- Should be primary lead for deliverables and participate in audits and inspections of the dedicated PV System.
- Should have solid understanding of pharmacovigilance principles and practices.
- Ability to multi-task, self-directed and independently handle multiple global stakeholders.
- Ability and willingness to be flexible, adapting to the demands of the customers.
- Exceptional interpersonal skills to interact with a variety of stakeholders and foster cross-functional/cultural teamwork.
- Ability to work in a fast-paced environment, maintaining flexibility and performing at a high level when faced with time constraints.
- Strong critical thinking skills to evaluate alternatives and present solutions consistent with business objects.
Requirements
installation/ configuration/ validation. PV Safety Systems , Oracle Argus Safety, Lifesphere Multivigilance
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