We can offer you skilled and experienced junior, mid, and senior consultants part-time, full-time, or assistance in recruitment into your company.
Our clients vary from small to medium to big global life science companies and the assignments can vary from national, and regional to global responsibilities.
We cover competencies within both human and veterinarian pharmaceuticals, medical devices, cosmetics, and food supplements.
Qualified Person responsible for Pharmacovigilance
Provision of QPPV, deputy QPPV.
Medically Trained Person
Provision of Physician or Veterinarian including 24/7 coverage.
National Contact person for PV
Provision of National Contact person for PV.
Audit
Audit of your PV System, Local Affiliate, Partner or Service Provider. Creation of Audit Strategy, Riskbased Planning and Program.
Inspection
Inspection readiness. Support before, during and after your Competent Authority Inspection by a former PV Inspector.
PV System
Gap analysis, set-up, development and maintenance of your PV System.
Quality System
Gap analysis, set-up, development and maintenance of your Quality Management System (QMS).
PV System Master File (PSMF)
Creation, update and maintenance of the PSMF.
Written Instructions
Creation, update and maintenance of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates etc.
Signal Management
Signal evaluation and handling including Signal Detection, Validation, Assessment, Prioritization and Actions.
Risk Management
Creation, update and submission of Risk Management Plan (RMP). Creation, implementation and tracking of Risk Minimization Measures (RMM).
Aggregate Reports
Creation and submission of periodic safety reports such as Periodic Safety Update Report (PSUR) and Annual Report (AR).
Computerized systems
User Requirement Specification (URS), due diligence, Computer System Validation (CSV).
Literature Search
Global and Local literature search.
Contracts
Vendor assessment, negotiation, set-up and maintenance of contracts, vendor management.
Case handling
Collection, validation, triage, follow-up, data management, coding, quality management, evaluation, submission and archiving.
