Maxwell Mascarenhas

• Generated 15+ aggregate safety reports including PSURs and DSURs ensuring compliance with global reporting timelines.

• Processed 12–15 ICSRs daily performing triage, case assessment, and MedDRA coding ensuring database accuracy.

• Identified and resolved 10+ database discrepancies improving reporting accuracy through E2B validation checks.

• Maintained audit readiness achieving 100% compliance across regulatory inspections and internal quality reviews.

• Facilitated 200+ safety submissions coordinating with stakeholders ensuring timely reporting and documentation accuracy.

• Conducted literature monitoring and signal detection improving identification of high-risk cases across safety datasets.

• Managed 200+ follow-ups monthly ensuring timely case closure and maintaining consistency across pharmacovigilance systems.

• Managed 5000+ adverse event reports ensuring regulatory compliance, accuracy, and timely submission across global safety systems.

• Conducted root cause analysis developing 5+ CAPA plans improving process efficiency and data integrity.

• Achieved 100% audit compliance through structured validation and corrective action implementation across submissions.

• Trained 10+ junior staff improving reporting accuracy, timelines, and analytical capability across operations.

• Delivered 60–70 safety reports daily within SLA timelines maintaining consistent performance benchmarks.

• Conducted signal detection improving risk identification rates by 15% across pharmacovigilance workflows.

• Maintained regulatory documentation including RSI and CCDS ensuring compliance with Health Canada standards.

• Coordinated daily follow-ups ensuring accurate case completion and resolution of missing safety information.