Prameela Rani Basa

• Prepared and submitted expedited and periodic safety reports (e.g., CIOMS, MedWatch, PADER, PSUR, DSUR) to global regulatory authorities in compliance with ICH and local regulations.
• Ensured timely submission of Individual Case Safety Reports (ICSRs) to regulatory agencies such as FDA, EMA, MHRA, and Health Canada.
• Coordinated electronic submission of safety reports via E2B-compliant systems, ensuring proper formatting and validation.
• Monitored submission deadlines and maintained submission trackers to ensure regulatory compliance and audit readiness.
• Collaborated with cross-functional teams (e.g., safety, regulatory, medical writing) to gather required information for accurate and complete reporting.
• Conducted quality checks of regulatory documents to ensure consistency, accuracy, and compliance with applicable guidelines.
• Assisted in the preparation of regulatory submission dossiers, including cover letters, narrative summaries, and data listings.
• Reviewed regulatory feedback and assisted in addressing queries or deficiencies related to submitted safety reports.
• Maintained up-to-date knowledge of evolving international regulatory requirements for pharmacovigilance submissions.

Triage and classify ICSRs based on report type, seriousness, causality, and labelling.

Prioritised ICSR according to regulatory requirements for efficient case management.

Completed remaining case data entry, including narrative and autonarrative.

Executed drug safety data management processes, ensuring quality and timeliness of deliverables.

Liaised with stakeholders to clarify necessary information for case processing.

Conducted quality reviews of ICSRs post-data entry, documenting results and identifying error trends.

Facilitated prioritisation of incoming cases to manage daily workflow effectively.

Participated in project teams aimed at enhancing ICSR quality through targeted training.

• Processed individual case safety reports (ICSRs) from clinical trials and post-marketing sources in compliance with global regulatory requirements.
• Entered and coded adverse events using MedDRA and WHO Drug Dictionary in Argus database.
• Ensured timely and accurate data entry and submission of ICSRs to relevant health authorities within specified regulatory timelines.
• Conducted initial triage and seriousness assessment of incoming safety data under the guidance of senior team members.
• Assisted in follow-up communication with reporters (HCPs and patients) to gather additional case information.
• Performed quality control checks on safety data and documentation to ensure compliance with SOPs and Good Pharmacovigilance Practice (GVP) guidelines.
• Supported literature screening activities by identifying and extracting relevant adverse event information.
• Participated in internal pharmacovigilance training sessions to stay up to date with evolving global regulations and practices.
• Collaborated with cross-functional teams including medical reviewers and regulatory affairs to support safety reporting.
• Maintained accurate documentation for audit readiness and regulatory inspections.