This role entailed the following:
A) Post-marketing signal detection and safety surveillance aspects
- Responsibility for product-safety life-cycle monitoring; this included:
- routine holistic, post-marketing signal-detection, timely escalation of safety issues, authoring signal-evaluation documents and expert reports/risk-management plans
- handling enquiries from Regulators/WHO/ethics committees, (PSUR-assessment reports, or post-approval commitments, and responses to literature-derived signals),
- routine reviews of autolistedness and autoseriousness terms for own products.
- Presented recommendations to the Global Labelling Committee for designated products (obtained several label-change approvals, and a Company-wide process-change with Licensees). Produced thereafter all necessary updates to Reference Safety Information.
B) Product-development and Regulatory aspects
- Supported the project-specific Safety-Review-Team Leader with product-development matrix duties (all phases), for:
- safety-related trial design and data-analysis matters (protocol/ISS/study-reports) and enquiries.
- safety documentation maintenance/creation (such as IB/DCSI updates and associated patient-information documents).
- Responsibility for marketing- and partner-company liaison, and support licensing applications/renewals and other Regulatory aspects world-wide by providing specialist safety evaluations.
C)Safety Operations aspects
- Authored/rolled out departmental procedures (e.g. IND/NDA/EU annual reports etc.) and improvements following efficiency/compliance monitoring to ensure output quality and fulfillment of Regulatory/Company statutory requirements.
- Ad-hoc member of the "PSUR-quality Team", and of the "MedDRA Steering Team".
- Collaborated with third parties to revise/create licensing agreements. Contributed to the safety-data-exchange-agreement process re-development including the construction of a Global Safety licensing database.
D) Compliance
- Worked closely with the company’s Legal team to address safety-document-retention and related global-safety processes issues to provide defense in product-related litigation cases.
- Experienced a routine FDA Pharmacovigilance inspection, and a triggered MHRA /EMEA Pharmacovigilance inspection (with remedial actions).
E) Systems implementation
- Appointed ”Expert User” on 2 matrix-based teams developing/piloting 2 novel systems; one using Observational/claims data (now known as SAEfetyWorks™) and the other integrating chemical/clinical data for signal-detection (GSK’s MCSI externally), prior to departmental roll out.