Patient Safety
Independent pharmacovigilance support for clinical and post-marketing safety.
Drug Safety Physician and Pharmacovigilance Leader.
Drug Safety Physician and Pharmacovigilance Leader for Interim and Ad hoc Support
Senior pharmacovigilance support when quality, speed and discretion matter.
Remote or hybrid engagements.
MD, EMBA - Pharmacovigilance - Signal Evaluation - Risk Management - Interim Management - AI-aware, compliance-first
How I can support your team
Ad hoc support
For peak workload, urgent safety issues, or expert medical input on short notice.
Interim leadership
Short-term to long-term coverage to stabilise teams, outputs and governance.
Part-time or full-time
Flexible support model depending on scope, timelines and internal capacity.
Core services
Pharmacovigilance
Across clinical studies and PMS, incl. due diligence and IDMC support.
Medical analysis
Clear medical reasoning and defensible documentation.
Signal evaluation
Signal detection support, evaluation and recommendation pathways.
Risk management
Risk assessment and risk minimisation strategy contributions.
Safety issue & crisis management
Structured handling, escalation, alignment, and fast action.
Regulatory interactions & submissions
Sound interpretation and convincing rationale.
Engagements are tailored to your PV system, timelines and regulatory expectations.
Where I support teams
I support safety organisations across clinical development and post-marketing, working closely with cross-functional teams to deliver high-quality, compliant outputs.
- Clinical studies : safety oversight, protocol and study documents input
- Post-marketing : medical assessment and safety strategy
- Signal evaluation : detection support, review, recommendations
- Risk management : benefit-risk assessment, risk minimization options
- Governance : safety boards, structured decision-making
- Communication : alignment across stakeholders under confidentiality
Expertise snapshots
Selected expertise snapshots
Snapshot 1
Context : Post-marketing portfolio with emerging safety concern.
Challenge : Rapid alignment on medical assessment and next steps.
Actions : Case review, signal evaluation support, risk options and documentation.
Outcome : Clear decision pathway, aligned stakeholders, compliant follow-up plan.
Snapshot 2
Context : Clinical development programme under tight timelines.
Challenge : Strengthen safety oversight and key document quality.
Actions : Safety input into clinical documentation, governance support, mentoring.
Outcome : Improved clarity, faster decision-making, stronger safety narrative.
Snapshot 3
Context : Team transition requiring interim coverage.
Challenge : Maintain continuity of outputs and processes.
Actions : Interim leadership, prioritisation, cross-functional coordination.
Outcome : Stable delivery, reduced operational risk, team upskilling.
Insights
Practical perspectives on pharmacovigilance, risk management and evolving industry practices.
Updated occasionally - not a news blog.