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 preferred
- 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 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
skills: Pharmacovigilance, Argus, Drug Safety
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, 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 HRsupport@randstadusa.com.
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 disability, 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.
