Services
Support tailored to pharmacovigilance, medical safety and interim leadership needs.
I provide senior-level support to pharmacovigilance and safety teams with a pragmatic, compliant approach. Engagements can be ad hoc, interim, part-time or full-time - remote, hybrid.
Drug safety physician activities
Outcome : Medical safety oversight across clinical development.
- Safety review and medical evaluation support
- Cross-functional collaboration and alignment
- Input into key safety documentation and decision pathways
Medical safety expert input
Outcome : Clear benefit-risk perspective and strategic safety input when it matters.
- Benefit-risk assessment and medical reasoning
- Regulatory interaction support (as applicable)
- Strategic input for development milestones and product lifecycle decisions
Signal evaluation support
Outcome : Structured signal evaluation with defensible documentation.
- Signal detection support and medical assessment
- Expert report and documented rationale
- Pragmatic actionable recommendations and risk minimisation options
Risk management
Outcome : Practical risk management aligned with governance and compliance.
- Risk evaluation and prioritisation
- Risk minimisation strategy input
- Contributions to risk management plans and supporting materials
Safety issue & crisis management
Outcome : Fast, structured handling of safety issues under confidentiality.
- Escalation support and issue assessment
- Stakeholder alignment and communication support
- Structured decision-making and action tracking
Interim management
Outcome : Continuity and stability during transitions or peak workload.
- Leadership coverage and fast onboarding
- Team mentoring and capability building
- Process continuity and delivery focus