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Pharmacovigilance





Pharmacovigilance

RPM’s experienced Pharmacovigilance team supports both CRO business and the pharmaceutical industry providing full-service medical and safety support throughout all phases of clinical development. Our Pharmacovigilance services comprehend technology support, safety management, regulatory reporting and post-marketing surveillance. Our Pharmacovigilance team has deep therapeutic expertise and is well-versed in regulatory requirements.


Our Pharmacovigilance services include:

  • Pharma Covigilance Consultancy
  • Project management
  • SOP Development
  • Safety Data Management Plan Development
  • Safety database Setup and Support
  • Reconciliation between Safety Database and Clinical Database
  • MedDRA/WHO-DD Coding
  • Medical monitoring
  • Global expedited safety reporting
  • Prompt reporting of potential expedited SUSAR’s (Suspected Unexpected Serious Adverse Reactions), IND and alert
  • SAEs/SUSARs monitoring
  • Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data Entry and maintenance
  • Case narratives
  • AE/SAE reconciliation
  • Case narratives
  • Case Collection including external/internal sources
  • Signal detection and evaluation
  • Global medical literature search & review in support of the DSUR
  • Eudravigilance reporting
  • Qualified Person for Pharmacovigilance (QPPV)/Eudravigilance Responsible Person
  • 24/7 Medical support
  • Generation of MedWatch/CIOMS I forms
  • Interim safety listings
  • Legacy Data Review and Transfer
  • Preparation of regulatory updates i.e. PSURs/PBRERs, PADERs, DSURs, etc. according to ICH guidelines
  • Periodic reporting of PSURs/PBRERs, PADERs and DSURs
  • Receipt and processing of Serious Adverse Event (SAE)/Serious Adverse Drug Events (SADE) and Adverse Event (AE)/Adverse Drug Event (ADE) reports
  • Case approval and drug safety reporting to EudraVigilance, IRBs/IECs, regulatory authorities and investigators
  • Data Monitoring Committee (DMC), Safety Review Committee (SRC) and Independent Data Safety Monitoring Board (IDSMB) formation and maintenance
  • Aggregate analysis and support for safety review committees
  • Measuring Regulatory Compliance and status reporting
  • Participation in Safety Advisory Board
  • Post-Marketing Pharmacovigilance services
  • Preparation and management of the Pharmacovigilance System Master File (PSMF)
  • Preparation and management of Risk Management Plan (RMP)
  • Study documentation, Investigator’s Brochure and protocol review and update
  • Reporter, team and site awareness and training

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