med-safe-solutions
Achieving the extraordinary - bringing determination and a spirit of adventure to delivering solutions in biopharmaceuticals
Bespoke & flexible to suit your business needs...
Offering a range of services to biopharmaceutical organisations across all disciplines of drug safety/pharmacovigilance, medical affairs, and compliance/medical governance.
Providing interim management, advice, consultancy, and training
Drawing on extensive experience from senior leadership in global safety, medical affairs and medical GxP compliance, underpinned by expertise in clinical practice and professional development including Fellowship of the Faculty of Pharmaceutical Medicine and maintaining General Medical Council license to practice
Safety
Experienced in leading global safety strategy and guiding clinical teams for products in a range of therapeutic areas and at all Phases of development, including post-marketing surveillance. Expertise in navigating complex stakeholder models and developing pharmacovigilance systems in Low Middle Income Countries (LMICs)
- Clinical development & regulatory safety strategy
- Risk management & post-marketing surveillance
- Periodic reports & safety labelling
- Signal detection and evaluation
- Worldwide regulatory responses / representation
Medical
Experienced in developing medical plans and supporting UK, EU and global brand teams. Expertise in management of medical functions including medical advisors/managers, medical science liaisons, medical information and medical monitoring of clinical trials.
- Launch support
- Lifecycle management (including CRO oversight)
- Key Opinion Leaders / Stakeholder management
- Medical governance
- ABPI nominated signatory
Compliance
Experienced in designing compliance frameworks, authoring SOPs, defining training curricula and delivering business-wide training programmes. Expertise in audit/inspections
- Medical and PV policy development
- SOP design & frameworks
- ABPI complaints & rebuttals
- Inspection readiness, preparation and oversight
Management
Experienced in recruitment, development and retention of employees in a range of medical and pharmacovigilance functions. Adept in leading cross-functional teams and project /budget management.
- General Medical Council appraiser
- PMST Educational supervisor
- Recruitment / retention
- Performance management, coaching, mentoring
- Training, workshop design/delivery
ABPI Code of Practice 2021
Effective from 1st July 2021, the updated Code has implications for company policies / procedures and staff training (including signatories). Support offered is informed by ABPI and PMCPA seminars, Joan Barnard 'Code in Practice' 7th Edition and Jayne Packham 2021 ABPI Code of Practice competence quizzesNew Paragraph
- What changed - 'Need To Know' training
- SOP / template updates & bespoke training
- Interim nominated signatory
