Close

Pharmacovigilance

The Pharmacovigilance department within Med Communications is able to assist your company in all facets of pharmacovigilance to ensure you meet your regulatory obligations. We can guide your company on the type of pharmacovigilance services needed, from specific pieces of pharmacovigilance to our “white glove” full-service end-to–end activities. We pride ourselves on maintaining an inspection-ready approach for all tasks performed and support our clients during inspection, taking responsibility for our outsourced work. We welcome the opportunity to discuss your company’s pharmacovigilance needs.

At Med Communications, we can provide you with a full pharmacovigilance department or specific pieces of the pharmacovigilance process customized to your needs.

Full Suite of Pharmacovigilance Services:

  • Case Management

    Case Intake

    • Manage intake and documentation of source information

    Case Triage

    • Conduct assessment of case specifics
    • Perform duplicate case checks
    • Perform medical assessment if needed
    • Perform additional triage per client request

    Case Reconciliation

    • Capture PC investigation results and reconcile AE/PC cases
    • Reconcile cases from call center
    • Reconcile cases sent by any other means (business partner, E2B, EDC)

    Case Processing

    • Perform case entry (enter case data)
    • Assess events for listedness/ labelness, and coding of patient history, product, and event information
    • Write narratives
    • Perform case coding activities (MedDRA, WHO Drug)
    • Prepare and conduct follow-up on cases as needed
    • Perform quality check and quality assurance activities on cases
    • Provide medical review to fully support medical assessment
    • Write periodic report case comments
    • Route case per workflow
  • Literature

    • Provide a validated literature database
    • Prepare literature strategy
    • Validate literature review parameters
    • Complete literature review
    • Monitor EMA medical literature
    • Identify terms
    • Monitor global medical literature
    • Identify terms of special interest
  • Regulatory Reporting

    • PADER
    • DSUR
    • PSUR / PBRER
    • IND Annual Report
    • Canadian PBRER
    • Non-expedited submissions
    • Routine safety listings
    • Expedited reporting
    • Marketed product
    • Clinical trials
    • Aggregate reporting
  • Risk Management

    • Aid in risk evaluation and mitigation strategies documentation
    • Provide guidance in REMS and RMPs and facilitate the elements of each document
    • Regulatory communications
    • Healthcare communications
    • Respond to ad hoc requests
    • Monitor effectiveness of safety mitigation measures
  • Signal Management

    • Aid in signal detection
    • Aid in investigation activities
    • Run reports to support signal detection activities
    • Track and document each signal or potential signal identified in client signal tracking tool
    • Provide evaluation and prioritization of confirmed signals
    • Prepare benefit-risk analysis and recommended action plan for the identified signal with input from PV physician and client personnel
    • Conduct routine safety surveillance meetings with client personnel
    • Assist client in determining appropriate communication plans as necessary for the identified signal and provide support for the communication plan
    • Coordinate and document periodic safety surveillance meetings by PV Specialist
    • Provide medical expertise and lead safety surveillance meeting activities by PV Physician
  • Regulatory Intelligence

    • Regulations/Guidanc
      • Monitor via Pink Sheet (weekly)
      • Monitor via Safety Observer (monthly)
      • Monitor RSS feeds from regulators
      • Monitor regulatory websites
      • Attend PV-related conferences/meetings
    • Database
      • Attend user group meetings to learn of new features and updates
      • Participate in testing and validation of new features and updates
      • Provide feedback on data tests, requirements, design specifications, new features to software developers
  • Pharmacovigilance Consultancy

    • Assist in building client PV department
    • Advise client with data migration and oversight
    • Help with data migration tasks and oversight
    • Provide guidance & supports in development of PV SOP’s
    • Onsite or remote regulatory inspection support
    • Support on safety database including due diligence, setup, configuration, validation, data, migration and activities

What is Pharmacovigilance?

What Is Risk Management?


Our Partners