Senior Scientist/Team Lead - Aggregate Reporting

📋 Description Author aggregate safety reports (PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, Ad-hoc safety reports) for Coordinate data contributions with stakeholders to prepare timely aggregate safety reports. Review safety data and assess events per sponsor conventions to ensure completeness. Perform global post-marketing case reviews to evaluate impact on safety profiles. Draft reports in templates based on evaluations and sponsor guidance; address review comments to 🎯 Requirements Bachelor’s or Master’s degree in life sciences or healthcare field. 5-8 years of domain experience with global regulatory and drug safety knowledge. Familiarity with safety databases (ARGUS, ARIS G) and drug safety processes. Strong verbal and written communication for global collaboration. Ability to manage multiple deliverables, maintain timelines, and ensure audit-ready outputs. Proficient in regulatory guidelines (GVP, ICH E2C/R2, EU MDR, 21 CFR) and quality/compliance 🎁 Benefits Remote work with global teams. Mentoring, training, and opportunities to lead in a regulated environment. Exposure to end-to-end pharmacovigilance and aggregate reporting operations.