Job Title: Data Architect, Global PV Systems

Job Location: Cambridge, MA, USA

Job Location Type: Remote

Job Contract Type: Contract

Job Seniority Level:

Job Summary

5 Month Initial Contract

REMOTE | EST Hours

Are you a Pharmacovigilance Technology Leader with deep expertise in PV systems, data architecture, and global reporting tools?

This is a rare opportunity to lead the reporting and analytics architecture of global PV systems at a major pharmaceutical company-ideal for someone who thrives at the intersection of Drug Safety and Data Engineering, and who can architect solutions, lead cross-functional initiatives, and drive strategic improvements across a regulated global environment.

What We're Looking For

10+ years in global pharma or biotech

5+ years in PV or Drug Safety systems

Strong experience in BI/reporting systems, data warehouse design, and regulatory compliance

Expertise in tools like Oracle SQL, Spotfire, Cognos, Argus, PL/SQL, and SDLC/CSV frameworks

Ability to lead projects, mentor teams, and drive process improvement in a regulated, global setting

location: Telecommute

job type: Contract

salary: $80.00 - 93.78 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

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

Qualifications

Bachelor's degree required; Advanced degree

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

Experience with Pharmacovigilance Drug Safety Systems, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS, etc ) business support and/or maintenance

Expert knowledge of database programming , 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

skills: Pharmacovigilance, Argus, Drug Safety

Equal Opportunity Employer: , , , , , , , , Genetic Information, , Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact .

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term , and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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