PV Aggregate Reports Scientist
Shivam SthapakRemoteMIDPosted 6d ago
PharmacovigilanceAggregate Safety ReportsPSURDSURPADERSafety Signal ManagementRegulatory LegislationScientific WritingCross-functional Collaboration
About the Role
SGS Consulting is seeking an experienced PV Aggregate Reports Scientist for a fully remote, 12-month contract position with potential for extension. This role involves leading and authoring aggregate safety reports and providing subject matter expertise in pharmacovigilance.
Key Responsibilities
• Lead and author aggregate safety reports, including PSURs, DSURs, PADERs, and local reports
• Provide subject matter expertise on global pharmacovigilance and aggregate reporting requirements
• Support safety signal management and responses to health authority inquiries
• Collaborate with PV Scientists, vendors, Quality Management, Regulatory, Clinical Development, and other cross-functional teams
• Support regulatory legislation reviews, impact assessments, and process improvement initiatives
• Maintain compliant and consistent global pharmacovigilance processes
Requirements
• Bachelor's degree in Biological or Natural Sciences; advanced degree preferred
• Minimum 5 years of pharmacovigilance experience
• Direct experience in aggregate safety report writing and safety signal management
• Knowledge of drug safety regulations, clinical trial safety, post-marketing safety, case processing, and expedited reporting
• Strong scientific writing, analytical, communication, and cross-functional collaboration skills