1 Oct 2020

Pharmacovigilance at OPIS

Pharmacovigilance is the set of activities aimed at identifying, evaluating, understanding and preventing adverse effects or any other problem relating to the use of medicines, to ensure a favorable benefit/ risk ratio for the population.

Drug safety data can be obtained from different sources: reports of suspected adverse reactions (spontaneous and non-spontaneous), clinical studies, scientific literature, reports from pharmaceutical companies, patients, health care professional, etc.

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 warrant compliance with regulatory and quality standards.
Our Safety vigilance Unit is staffed with Eudravigilance-certified teams that provide a wide range of services, including:


  • 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


  • 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


  • 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

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

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