About
An independent, physician-led pharmacovigilance practice
Safety Strategy gives pharmaceutical and biotech companies direct access to senior drug safety expertise, without the overhead of a large agency.
Background
Safety Strategy was founded by a physician and pharmaceutical medicine specialist with close to two decades of drug safety leadership across big pharma and biotech, from first-in-human to post-marketing, including global filings in the EU, US, China and the rest of the world.
My experience covers clinical and post-marketing safety, building and leading safety teams, product safety strategy, signal management and benefit-risk assessment, risk management including EU RMPs, US REMS and additional risk minimisation measures, and PV quality, audits, inspections and the PSMF.
I work in English and French, with clients in Switzerland and internationally.
Principles
How I approach drug safety work
Proportionate
Processes and documents sized to the product, the stage and the regulatory requirement, not to a template.
Documented
Safety decisions recorded so that they can be followed by an assessor or inspector years later.
Independent
Medical judgement given directly, with no sales targets attached to the advice.
Work with Safety Strategy
Describe the question or project and I will reply personally.