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Pharmacovigilance services in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) is the main authority under the Ministry of Health (MOH) for the safe use of food, drugs, and biological and chemical substances. Under SFDA the National Pharmacovigilance Centre (NPC) was launched as its pharmacovigilance sub-division: with a focus mainly on the safety profiles and ensuring a positive benefit-risk for all the medications. Since its establishment, most pharmacovigilance services, such as adverse drug reactions (ADRs) reporting, risk management plans (RMPs), Periodic Safety Update Report/Periodic Benefit-risk Evaluation Report (PSUR/PBRER), individual case safety report (ICSR), signal detection, data mining, and risk communication, are a part of NPC. Adverse reactions can be reported by physicians, pharmaceutical companies, and the general public online or by email, by filling out paper forms and sending them by email, fax or mail or by call and report the ADRs. In addition, Saudi Arabia requires a dedicated QPPV residing in the country to oversee the pharmacovigilance activities. For international Marketing Authorization holders, it is mandatory for them to develop and maintain a local pharmacovigilance services in Saudi Arabia. which is documented in a file called “Pharmacovigilance Sub-System File (PSSF),” Also, the local MAHs document the ADR information in the company’s global PV system Pharmacovigilance System Master File (PSMF). Although, Saudi Arabia has an advanced PV system in place, underreporting from the public and lack of PV awareness are some of the pharmacovigilance challenges faced.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Saudi Arabia that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, periodic safety update reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

Responsible Person for Pharmacovigilance (RPPV)/QPPV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV and Deputy
  • Local Safety Responsible
  • Medical review of Signal detection ; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight
  • Monthly reconciliation

PV Audit & Compliance

  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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