About our client:

Requirements

JOB DESCRIPTION

• Experience: 12 -18 Years
  
• Location:
  East Coast, United States
  
• Employment: Full Time
  

Role and Responsibilities:

• 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.
  

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 objects.