Specialists in Pharma, Clinical & IT Recruitment

PVG and Drug Safety

 

PVG and Drug safety is concerned with the monitoring, research and assessment of products in order to seek any new and adverse side effects that may have arisen since the clinical development stage. Their role is focused on safety reporting for marketed products and risk management. They also make sure that all new information is made available to patients to inform them of the safe and effective use of the product.

We focus in the areas of:

  • Drug Safety Risk Management
  • Writing Risk Management Plan for Marketing Authorisation Application Dossier
  • Provision of QPPV Services 
  • Signal detection, analysis and evaluation
  • Product Risk Management (RiskMAPs; REMS and RMPs); PIPs
  • PV systems Validation
  • PV Inspections / Audit (FDA, EMA, MHRA others)
  • Medical review
  • SAE processing
  • Medical management
  • Good Clinical Practice
  • Medical monitoring
  • Aggregate reporting
  • Global Safety Surveillance

We cover the following roles:

  • Drug Safety Assistant / PVG Officer
  • Drug Safety Officer 
  • Drug Safety Physician and Medical Safety Advisor
  • Senior Drug Safety Physician
  • Senior PVG Manager / Drug Safety Manager
  • Director of Drug Safety or PVG
  • Hybrid roles such as Regulatory / PVG

 

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