Jobs → Customer Support → PV Aggregate Reports Scientist

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

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