This role entailed the following:
A) Safety surveillance aspects
- Global responsibility for analysing/reviewing safety information from a varied sources, including the monitoring of all safety-related matters (device incident, product complaints) throughout the entire life-cycle of designated biological products.
- Also held parallel UK-affiliate’s drug-safety duties including UK Medical information/Regulatory Affairs/Sales and Marketing (product-lifecycle) teams support.
- Accountable for case-report assessment/processing/follow-up (all sources) through daily supervision/support/training of a team of 4; management of case-processing-related quality/time metrics, and report-quality reviews before submissions.
- Accountable for assistance/liaison with/to local affiliates’ or Manufacturing-site staff responsible for (product-complaint) safety-related activities to foster global alignment and compliance with local/global pharmacovigilance requirements.
B) Safety Operations aspects
- Co-created a Pharmacovigilance-centralisation project involving affiliates‘ legislation examination, SOPs review/creation, gap-analysis, and global training to mitigate organizational-risk (this implied restructuring processes, task-assignment, job roles/accountabilities across Central-Safety sites and case-processing teams; resulting in streamlined activity and improved integration of local-safety representatives).
C) Product-development and Regulatory aspects
- Provided pharmacovigilance steer for clinical development programs, and actively involved in clinical-submission strategies towards a BLA challenging a competitor’s orphan status in the USA as well as the preparation for an NDA application, including:
- planning (indication/filing strategy/dose-escalation reviews)
- liaison with internal and external stakeholders/partners/IDMCs.
- Input into the design, monitoring, evaluation and reporting of clinical trials safety data, a
- review of protocols/IBs, consent forms etc.
- Led Investigators/site-staff and CRA safety-training and acted as 24h safety-contact-point for 7 Clinical trials (all phases – see therapy area summary for details).
- Negotiated services with specialist external pharmacovigilance suppliers (CRO/vendors proposal-assessment) and monitored agreed deliverables.
E) Compliance
- Closely worked with the Global Pharmacovigilance Systems Manager to complete a validated migration to MedDRA, and later, successful E2B implementation.
- Deputised for the Head of Pharmacovigilance for third-party audits/due-diligence (actively involved in a mock FDA-audit, an actual MHRA Pharmacovigilance inspection with favourable outcome, and an international safety-issue-detection/review leading to a class-2 Regulator-supported drug-recall).