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.