17 Feb

Drug Safety Configuration Lead - - Foresight Group International

Drug Safety Configuration Lead
Foresight Group International
17 Feb, 2017 30+ days ago

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Job Type
Full-Time Regular

Job Description
Role Definition

Involve in configuration of Pharmacovigilance / Drug Safety Adverse Event Reporting Systems at Pharmaceutical companies which includes understanding Business and Functional requirements, prepare design strategy, develop and implement optimized solutions using prototyping and POC techniques where required.

Job Duties

Key components of the responsibilities are as mentioned below:

  • Provide application configuration expertise on Adverse Event Reporting products including Argus Safety, ArisG and related modules
  • Requirements Analysis
  • Development and accountability of document deliverables ( Requirement Documents CBD/CS UDDs SCR Verification IQs etc.)
  • Design, build and implement configuration for clients
  • Conduct POCs to understand the effectiveness of the solution; incorporate feedback into the solution
  • Closely work with clients to support implementation and resolve issues
  • Implement Quality measures to drive operational efficiencies and articulate the value to the customer

Education & Other Qualifications
  • BE/ME/MCA/MCS/MSc degree from reputed Institute/University

  • 6-9 years of professional experience and strong knowledge with real time experience in Drug Safety Products from Oracle/Aris Global – Argus/ArisG
  • Implementation/Upgrade/Maintenance of Drug Safety Application
  • Working knowledge of writing SQL queries and/or PL/SQL code
  • E xperience in handling a team
  • E xcellent communication, consulting and inter-personal skills
  • Ability to multi-task and work well under pressure
  • Commitment to excellence and high quality standards
  • Versatility, flexibility, and a willingness to work within changing priorities
  • International travel readiness, work hours that overlap global client location Time-zones

N i c e to Have Skills
  • Working experience on associated modules like Argus J, AgExchange/ESM
  • E xperience in Customizing E2B profiles
  • E xperience in configuring Aggregate and Periodic reports
  • Knowledge of regulatory guidelines from the Food and Drug Administration ( FDA), EMA and PMDA

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