Remote Consultant, Reporting and Analytics, Global Safety Systems (CST and EST Candidates Preferred)
12 Month Contract
$80/hour - $90/hour W2
Position Overview
This role will partner closely with Safety and Risk Management stakeholders to develop, validate, and maintain reporting solutions that support pharmacovigilance and drug safety operations.
The ideal candidate will bring strong expertise in pharmacovigilance reporting, safety analytics, report development, validation, and stakeholder collaboration, with hands‑on experience using industry‑standard reporting tools such as PV Reports, Oracle Analytics Server (OAS/OBIEE), BI Publisher, or Cognos.
This is an excellent opportunity for a seasoned reporting and analytics professional to support critical global safety initiatives within a highly collaborative and mission‑driven environment.
Key Responsibilities
- Generate safety data reports, listings, visualizations, and analytical outputs to support pharmacovigilance activities.
- Collaborate with Safety and Risk Management (SRM) stakeholders to gather, document, and refine reporting requirements.
- Develop, test, validate, and maintain reporting solutions supporting global drug safety operations.
- Produce reports supporting: Medical Monitoring, Signal Detection, Aggregate Safety Reporting, PBRERs (Periodic Benefit‑Risk Evaluation Reports), and DSURs (Development Safety Update Reports).
- Coordinate data requests with database service providers and verify report outputs against business requirements.
- Perform quality review and validation of reporting deliverables, resolving discrepancies when identified.
- Monitor ETL processes, scheduled report execution, and reporting workflows to ensure system reliability.
- Create and maintain reporting schedules to support on‑time delivery of safety reports.
- Support qualification and validation activities for Global Safety Systems applications and reporting tools.
- Ensure compliance with applicable pharmacovigilance regulations, ICH guidelines, and internal procedures.
Required Qualifications
- Completed Bachelor's or Master's degree in Computer Science, Information Systems, Life Sciences, or a related field.
- 5-10 years of experience in reporting, analytics, or systems support within a pharmacovigilance or drug safety environment.
- Strong experience developing and supporting reporting solutions in regulated pharmaceutical or biotechnology organizations.
- Experience working directly with business stakeholders to translate reporting needs into actionable solutions.
- Ability to work independently in a remote environment while managing multiple priorities.
Required Technical Skills
Candidates must have hands‑on experience with the following:
- PV Reports (strongly preferred)
- Oracle Analytics Server (OAS)
- Oracle Business Intelligence Enterprise Edition (OBIEE)
- BI Publisher (BIP)
- Cognos
Additional experience with:
- Report Development & Validation
- Report Scheduling & Monitoring
- ETL Process Monitoring
- Quality Review & Data Verification
- Pharmacovigilance Reporting Systems
Preferred Experience
- Drug Safety and Pharmacovigilance reporting
- Aggregate reporting activities
- Medical monitoring data reporting
- PBRER and DSUR report generation
- Safety data extraction and analysis
- Validation and qualification of GxP systems
- Regulatory compliance and ICH guideline familiarity