USA - Data Scientist Architect

  • Cambridge, MA
  • Posted 19 hours ago | Updated moments ago

Overview

On Site
$72 - $96 hr
Full Time
Contract - Independent
Contract - W2
Contract - 5+ mo(s)

Skills

PHARMACOVIGILANCE
DRUG SAFETY
DATAWAREHOUSE
DATA ANALYSIS

Job Details

Data Scientist Architect
Remote (EST./CST Zone preferred)
6+ months role
Pay rate:- $75-85/Hour on W2

Job Description:-

Position Title: Assoc. Director, PV Systems Reporting & Analytics
Function: Global Pharmacovigilance
Department: Global PV Operations

OBJECTIVE:

  • Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) database
  • Provide technical and strategic input into the roadmap, planning, and implementation of projects associated with the global PV database reporting and analytics systems
  • Work collaboratively with global PV functions, support and validation roles, IT and Quality Assurance to ensure global PV reporting systems meet the needs of the user community and relevant regulations
  • Contribute to oversight of vendor outsourced PV reporting activities

ACCOUNTABILITIES:
  • Lead delivery of PV reporting and analytics systems projects in coordination with IT
  • Lead selection and delivery of new applications to support self-service reporting and analysis of PV data
  • Lead continuous improvement to PV reporting and analytics systems with focus on integration of (external) data sources, automation, and industry standard dashboards
  • Provide SME input into development of roadmaps / plans for implementing complete range of Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc.) in response to global PV requirements and related driving regulatory guidance
  • Develop and ensure delivery of relevant PV reporting and analytics systems SOPs and training
  • Proactively identify PV reporting and analytics systems requirements in collaboration with business, IT, Quality, and other stakeholders
  • Provide mentoring and training to members of the PV Systems team and GPSE user community to build a bench of knowledge at varying levels throughout the organization
  • Perform audit / inspection support related to Global PV Reporting and Analytics functions and activities
  • Development, tracking, and reporting of quality metrics for Global PV reports

EDUCATION:
  • Bachelor s degree required; Advanced degree preferred
  • Experience with Pharmacovigilance Drug Safety Systems, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS, etc preferred) business support and/or maintenance
  • Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting, etc
  • Strong understanding of Software Development Life Cycle (SDLC), including requirements gathering, technical design, and unit to system and user acceptance testing
  • Experience with Computer Systems Validation, including understanding of 21 CFR Part 11, GxP compliance and validation in a regulated environment
  • Process oriented focus
  • General knowledge of drug development process, including excellent knowledge of Pharmacovigilance regulations and guidance as applies to regulated PV computer systems
  • Excellent analytical skills
  • Excellent written and verbal communication skills
  • Excellent organizational and time management skills
  • Working knowledge of MedDRA
  • Ability to establish sound working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds
  • Contribute to oversight of outsourced Global PV reporting activities

ADDITIONAL US SPECIFIC INFORMATION:
  • Minimum of 10 years pharmaceutical or healthcare related industry experience required
  • Minimum of 5 years pharmacovigilance or drug safety related experience
  • Minimum of 5 years technical systems experience required in database report development, business intelligence, and/or data warehousing

Kind Regards,
Bhavesh


Bhavesh Singh Chauhan
Delivery Manager - Recruitment
Apolis
Cell ()
Email:

703 Campus Square West, El Segundo, CA 90245

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