Safety Vigilance

OPIS offers a comprehensive and flexible suite of safety monitoring services such as pharmacovigilance, phytovigilance and Medical Device Vigilance and Surveillance, for drugs, nutraceuticals and medical devices. From early development support through post-approval initiatives, our objective is to ensure that the risk-benefit profile of products is closely monitored. This ensures the maximisation of product potential whilst ensuring patient safety at all times. Regular audits ensure compliance with regulatory and quality standards.


Our Safety vigilance Unit is staffed with Eudravigilance-certified teams that provide a wide range of services, including:

Pharmacovigilance in clinical studies

  • Preparation of the Safety Data Exchange agreement (SDEA) or Safety Management Plan (SMP) for open-label and blinded studies
  • Collection, assessment and reporting of Adverse Events (AEs) originating from clinical studies
  • Query management and follow-up
  • MedDRA coding
  • Set up and implementation of a validated eSafety tool module for the collection and reporting of AEs, SAEs, Pregnancy cases and Product Quality        Complaints through electronic systems
  • SAE Reconciliation Process
  • SUSAR Submission through the Eudravigilance database
  • SUSAR submission to local regulatory authorities through our subsidiaries
  • Management of SUSARs Line Listing: list drafting and distribution
  • Development and submission to the Health Authorities (safety report) of Development Safety Update Reports (DSURs)
  • Wide experience in european regulatory requirements for pharmacovigilance (Regulatory intelligence)
  • Medical Review

Pharmacovigilance post marketing

  • Preparation of the Safety Data Exchange agreement (SDEA) or Safety Management Plan (SMP)
  • Participation in Safety Advisory Board
  • Case processing (ICSRs) and reporting
  • Management of local literature screening
  • Pharmacovigilance Business Continuity on holidays
  • Medical Review


  • Preparation of the Safety Data Exchange agreement (SDEA) or Safety Management Plan (SMP)
  • Collection, assessment and reporting of Adverse Events (AEs)
  • AE Reconciliation Process

Medical device vigilance and surveillance

  • Preparation of the Safety Management Plan (SMP) for Medical Device (In-Vitro Diagnostics Device -IVD- and Medical Device -MD-)
  • Management of Medical Device safety information (-IVD and MD) from Clinical Investigation and Post-Marketing Surveillance
  • Processing of a Medical Device Incident (MDI), Adverse Device Effects (ADEs) and Deficiency
  • Reporting of MDI/ADE to the Regulatory Authorities
  • MDI/ADEs reconciliation

Other activities

  • Set up and management of the Compassionate Use Programs (CUP)

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Whether you are Sponsor, a Clinical Research Professional or an Investigator contact us to learn more about how we can help.

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