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Marketed Products

PPD’s global pharmacovigilance group gives clients access to scalable, flexible technologies and resourcing solutions, and effective governance and continuous process improvement to meet the increasingly complex regulatory requirements for marketed products.

By placing services in distinct geographical locations, PPD’s post-approval approach provides, when needed, 12 hours per business day, which helps minimize risks to continuity. Global locations, including Bulgaria and the Philippines, are selected based on educational expertise in healthcare and life sciences, high levels of English proficiency and overall cost-effectiveness for clients.

Safety management programs for marketed products can be controlled with confidence. PPD’s motivated pharmacovigilance team offers organizational stability that comes with years of experience within the company, expertise from extensive onboarding and continuous training processes, and firsthand knowledge of complex regulatory requirements.

PPD’s comprehensive and flexible suite of pharmacovigilance services include:

 
Adverse event (AE) management
  • Intake
  • Triage
  • Case processing (PPD or client-provided database)
  • Narrative development
  • Medical review
  • Follow-up collection
  • AE reconciliation with call center
Safety database services
  • Database setup, implementation and maintenance
  • Data migration
Global literature database search strategy and review in support of
  • Individual case safety report detection
  • Aggregate safety report development
  • Signal management
Individual case reporting
  • Post-approval (e.g., (S)ADR) reporting to regulatory authorities
Aggregate report management
  • Development (e.g., PBRER, EC2-R1 PSUR, PADER)
Signal management
  • Detection
  • Validation
  • Evaluation
  • Tracking

Region-specific Services 

PPD also offers regional services to meet your complex global regulatory needs, including but not limited to:

  • Adverse event intake via MedComm medical information function
  • EudraVigilance profile management
  • European Union-qualified person for pharmacovigilance (QPPV)
  • In-country pharmacovigilance services, including national contact persons/QPPVs and local literature surveillance
  • Japanese safety database, including PMDA ICSR submissions
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