MSI Pharma are working with an exciting oncology focussed biotech company that are seeking an experiences Safety Physician who will be working on BLA/MAA submissions, global safety strategy and working closely with global regulatory agencies.
The main responsibilities are:
- Oversight of, and accountability for the quality performance of one or more safety management team(s) that each are responsible for the safety monitoring, signal management and benefit risk assessment of a program;
- At portfolio level, the responsibility to formulate and drive the optimal development safety strategy for the respective oncology programs in clinical development;
- Where applicable, presentations on safety matters at regulatory authority meetings;
- Responsibility for a regular assessment of the Benefit Risk assessment of the products in development; may decide that an emergent safety issue/product alert deserves escalation up to the executive safety governance body for arbitration and/or action;
- Leadership to ensure that single case reporting, signal management and risk management activities which occur under his/ her direction and competence, are performed at all times in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards;
- Oversight on the quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator's brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries and other clinical/regulatory documents as needed;
- Participation in due diligence for BioNTech's Licensing /Acquisition initiatives; assure the representation of medical safety in Alliance management projects such as safety data exchange agreement negotiations; representation of medical safety in joint oversight committees with development partners, or participation in other collaborative development projects;
- The Safety Strategy Lead is the safety subject matter expert at the portfolio level and is the arbiter for safety related issues in any of its constituting programs, as they may arise.