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Subject Matter Expert in Pharmacovigilance

2 months ago

Jersey City, New Jersey, United States YD Talent Solutions Full time
Job Title: Subject Matter Expert

We are seeking a highly skilled Subject Matter Expert to join our team at YD Talent Solutions. As a Subject Matter Expert, you will be responsible for providing expertise in Pharmacovigilance and PV Safety Systems.

About Our Client

Our client is a leading provider of Pharmacovigilance solutions, bringing together expertise in Pharmacovigilance, Third party system knowledge, and Deep technology to develop well-defined solutions that address challenges across Medical Affairs, Regulatory, and Safety functions.

Job Description

The ideal candidate will have excellent functional knowledge of PV Safety Systems like Oracle Argus Safety, Lifesphere Multivigilance, etc. and experience in installing, configuring, and validating these systems.

Responsibilities
  • Attend all meetings as a PV Systems subject matter expert (SME)
  • Participate in and contribute to safety system design requirement specifications for the safety database as a PV Systems SME
  • Provide vendor/client oversight of report development: Compliance, Aggregate, Signal Detection, Data Mining, Key Performance Indicators (KPIs)
  • Review and provide feedback on templates (including team member training) on Tenant Configuration, Business Configurations, Code List changes, and User Permissions
  • 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.
  • Be the primary lead for deliverables and participate in audits and inspections of the dedicated PV System
  • Have a solid understanding of pharmacovigilance principles and practices
Behavioral Skills
  • 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 objectives