Safety strategy and interim leadership
Product safety strategy across the lifecycle, interim Head of Drug Safety cover, and safety team build-up plans.
DetailsPharmacovigilance and safety risk management
Drug safety strategy, from first-in-human to post-marketing.
I help pharmaceutical and biotech companies build and run proportionate, inspection-ready pharmacovigilance: safety strategy, signal management, RMP and REMS design, PSUR/PBRER strategy and inspection readiness.
Book an introductory callServices
Senior drug safety support for biotech and pharma
Whether you are preparing a first marketing application, building a safety function or facing a GVP inspection, I provide hands-on, senior-level support, scoped to your stage.
Signal management and benefit-risk
Signal detection, validation and evaluation in line with GVP Module IX; benefit-risk assessments.
DetailsRisk management
EU RMP updates, US REMS design and additional risk minimisation measures (aRMMs).
DetailsFilings and aggregate reports
Safety strategy for global submissions; PSUR/PBRER and DSUR strategy and medical review; Health Authority responses.
DetailsPV system and inspection readiness
GVP gap assessments, PSMF maintenance, audit preparation and inspection-day support.
DetailsPV training and education
In-house workshops for safety and clinical teams, plus courses, slide decks and templates in the shop.
DetailsBackground
Industry experience, applied to your programme
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.
- Medical and scientific safety judgement from a physician
- Experience from first-in-human through phase III and post-marketing
- Work scoped to the size and stage of your company
- Clear communication with cross-functional teams and regulators
- Close to 20 years
- in industry drug safety, since 2007
- Big pharma and biotech
- global safety leadership roles
- EU, US, China, rest of world
- global regulatory filings
- Clinical and post-marketing
- accountability for both phases of safety
How I work
Four steps, clearly scoped
Introductory call
A short conversation about your products, stage and needs.
Assessment
Review of your current PV set-up, resources and priorities.
Proposal
A written scope, timeline and fee, as a project or a retainer.
Delivery
Hands-on work with regular check-ins and defined deliverables.
Education
PV education resources
Self-paced courses, editable slide decks and practical templates for pharmacovigilance professionals and teams.
Discuss your safety needs
Tell me about your product, timeline and question. I will reply personally.