Assoc. Director, PV Systems Reporting & Analytics

Overview

Remote
Depends on Experience
Contract - W2
Contract - 05 Month(s)
10% Travel

Skills

Dashboard
Collaboration
Communication
Computerized System Validation
Continuous Improvement
Acceptance Testing
Analytical Skill
Analytics
Matrix Management
Health Care
IBM Cognos Analytics
IT Management
Inspection
Management
Auditing
Business Intelligence
Data Warehouse
Database
FOCUS
Shell Scripting
Quality Assurance
Regulatory Compliance
Reporting
Requirements Elicitation
GxP
Mentorship
Microsoft SSRS
Microsoft Windows
PL/SQL
TIBCO Spotfire
Technical Drafting
Training
Pharmaceutics
Roadmaps
Software Development
Software Development Methodology
Unix

Job Details

Position Title: Assoc. Director, PV Systems Reporting & Analytics Job ID: 25-09090 Location: Remote Duration: 05 months on W2 Contract

Top skills:
  • Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experience
  • Strong matrix management skills

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, BEHAVIOURAL COMPETENCIES AND SKILLS:
  • 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.

TRAVEL REQUIREMENTS: Some travel to global Client sites may be required.

Compensation:

The hourly rate for this position is between $73.00-$97.00 per hour.

Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].

Benefits:

Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.