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Sr Analyst, IT (L3 Support for Argus)

5.00 to 6.00 Years   Hyderabad   08 Jul, 2021
Seneos Health
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

*JOB SUMMARYThe position is responsible for designing, building, installing, configuring and supporting Safety & Pharmacovigilance COTS applications to meet business process and application requirements according to best practices and guidance within the company.JOB RESPONSIBILITIES

  • Participates in the delivery and support of technology solutions for the Safety and Pharmacovigilance department.
  • Participates in all areas of the project/system lifecycle including analysis, design, development, implementation, support and enhancement.
  • Enhances/develops existing safety system software to adapt to new requirements.
  • Assists with requirements gathering and analysis for safety system configurations, upgrades, data updates, data migrations and reporting.
  • Identify and analyze user requirements; determine feasibility of requirements; propose design, development and implementation approach.
  • Implements Argus version upgrades and patches.
  • Develops SQL/scripts/procedures for required backend updates.
  • Authoring and accountability of document deliverables (technical design documents, IQ, OQ).
  • Development, execution and monitoring of the qualification deliverables (IQ and OQ scripts, results)
  • Ensures all Changes and requests are documented and completed with proper documentation for business compliance and/or GxP compliance.
  • Participate and lead safety system L3 support tasks providing technical expertise on safety database.
  • Analyzes and resolves L3 production support tickets. Troubleshoot and identify key issues in complex situations, and formulate/execute issue resolution with minimal assistance
  • Collaborates with other BT support groups and other business groups to fulfill project and operational requests and issues.
  • Provides timely and clear communications with customers (end-users, IT, and business groups).
  • Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
, *QUALIFICATION REQUIREMENTS Education:
  • BA/BS Degree in Computer Science or related discipline or equivalent work experience.
Experience / Knowledge:
  • Required: Minimum 5-6 years of professional experience in development role.
  • Required: Demonstrated knowledge of Argus Safety 8 or higher, Oracle Database 12c or higher, PL/SQL
  • Required: Thorough knowledge of Argus Safety 8 or higher, E2B R2/R3, pharmacovigilance operations, GxP compliance, computer system validation, system development life cycle.
  • Required: Demonstrated experience with Argus database structure, Argus application architecture, Argus console configurations, ESM module configurations (configure profiles/DTDs), Argus upgrades/patches, database updates, data migrations.
  • Required: Working knowledge of system analysis, design, security methodologies, software installations, and trouble-shooting techniques.
  • Required: Broad knowledge/understanding of relevant ICH guidelines, as well as FDA and EU regulations
  • Preferred: Experience with Jira, Oracle Apex, Axway
  • Excellent verbal and written communication skills.
  • Strong customer management and service skills.
  • Excellent problem analysis and problem resolution skills.
  • Ability to learn new technologies quickly.
  • Ability to work independently under strict deadlines and changing priorities
  • Ability to multitask and prioritize changing workload; must be well organized
  • Ability to work with culturally diverse and virtual teams.

Keyskills :
computer system validationstandard operating proceduresoracle apexmusic makingargus safetysupport groupsoracle databasestatements of work sow

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