I love solving problems..

Living and breathing Pharmacovigilance since 1999..  I worked under successive Regulatory changes, their management and impact on Pharmaceutical Research and Patient Safety. 

Below is a sample list of challenges that I have tackled throughout my career to date.  
This topics and issues below are in no order of simplicity, merit, or preference. Some were encountered recurrently across different Companies. I only listed topics I can do in details, or teach about.  

I hope this sample helps you gauge how where I may be a good option for your needs.

Pharmacovigilance Framework

  • Standard Operating Procedure authoring
  • Process-gap analysis and organizational risk across Medical/Pharmacovigilance systems and processes (and CAPA-management)
  • Pioneering new initiatives (including Regulatory) and Championing
  • Mapping pharmacovigilance framework towards a DDPS creation (and conversion to PV Master file)
  • Monitor key aspects of a Pharmacovigilance quality-management system and support the role of QPPV (like SDEA compliance)
  • Clinical Investigators/site-staff and CRA safety-training and emergency-safety-contact
  • Label/CCSI revamp (and removal of adverse events from)
  • IT tool Design/creation/pilot and roll-out to support Pharmacovigilance endeavours
  • Programmatic data-extraction specifications and validation
  • mHealth solution design and evaluation
  • CRO management and Consultants’ contracts reviews
  • Bidding algorithm and contract templates
  • Office/staff relocation planning and execution

Safety Analyses

  • Signal detection and reviews in various Therapeutic areas (drugs/devices/biologics)
  • Hazard characterisation and implementing/assessing risk-mitigation measures 
  • REMS/RiskMAP/EU-RMP development and monitoring
  • Novel clinical study design and associated risk-management (c.f. GSK' Salford Lung Study)
  • Safety plans and integration for large clinical programs
  • Design and validation of safety-data reports (in SAS and in Data-visualization systems)
  • Paediatric Investigation Plan design and safety-management
  • Design novel safety surveillance programs (e.g. flu pandemic; advanced medicines)
  • Safety Monitoring Committee Leadership
  • Consumer-product risk-assessment
  • Meta-analysis for safety endpoint
  • Risk-communication material
  • Observational databases training

Patient Data Management

  • Pharmacovigilance Coding Manual (re)-design 
  • Identification of case-processing/migration inconsistencies
  • Creation of targeted-follow-up questionnaires
  • MedDRA implementation and training
  • Case-report filing-room and -system design with workflows
  • Pharmacovigilance database migration

Regulatory Interactions

  • Risk-management discussions with Authorities
  • FDA Ad-Com representation
  • NICE (UK) committee interaction
  • EMA/MHRA/FDA inspections (inc. for-cause) under GVP/GCP/GMP
  • Regulatory submission/strategy planning and support of global (Biologic) Clinical program and licensing
  • Product adulteration and world-wide recall (Drugs/Devices Safety action)
  • Piloting of many Regulatory changes, like EU RMP implementation, DSUR implementation (first 4 among first 12 in GSK), FDA Final Rule for INDs, etc.

Partners Network

  • License-partner safety-data-exchange agreements drafting and redressing lack of compliance
  • Pharmacovigilance merger process redesign
  • Global Labelling process-management issues (with License partners)
  • Audits
  • Due-diligence