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PV Consultant
4 months ago
Role: PV Consultant
6 month contract
Inside IR35
Onsite 3 days per week in London
Working closely with the wider clinical development team, this person will be required to understand, cleanse, and present clinical safety data sets in an early stage/ pre-marketing environment.
Responsible for:
- Day-to-day pharmacovigilance oversight: Review SAEs and queries to investigators on a regular basis, support the data cleaning for safety data, and oversee signal management to identify significant trends.
- Case processing: Manage PVG processes for serious adverse events (SAEs) and adverse events of special interest (AESI), work with data management and clinical operations to ensure data entry meets requirements, and oversee any regulatory reporting or actions required.
- Oversight and support of periodic drug safety compliance activities: Update DSUR and IB, support preparations for IDSMC meetings including interpretation of safety data from tables and listings.
- Consulting on process improvement: Support our ongoing data management transformation initiative, reviewing current processes for pharmacovigilance and safety risk management and providing input on transformation plans.
Deliverables:
- Input to data management transformation initiative e.g. recommendations for Risk Evaluation and Mitigation Strategy (REMS) and safety data review processes.
- Clean safety data
- Reviewed SAEs and queries Timely reporting and regulatory submissions for AESI/SAEs
- Contribution to IDSMC readiness
- DSUR/IB