Pharmacovigilance Services in Jordan

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Jordan, explore DDReg’s specialized pharmacovigilance services in Jordan to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with Jordan FDA pharmacovigilance guidelines, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorization.

As a leading global contender, DDReg understands the significance of patient safety 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 Jordan, including adverse drug reaction reporting, signal detection and management, aggregate report writing, and the development of customized pharmacovigilance plans/risk management plans in accordance with local requirements and good pharmacovigilance practices.

Ensure compliance with Jordan FDA pharmacovigilance guidelines and safeguard patient safety by partnering with DDReg, your trusted pharmacovigilance consulting firm in Jordan. Our comprehensive services support you throughout the product lifecycle, from clinical trials to post-marketing surveillance. Contact us today to learn how we can assist you in navigating Jordan's pharmacovigilance landscape.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases integrated with drug dictionaries (WHO DD) and MedDRA
  • Quality checks and medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring and 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 plans
  • Assessment of potential risks and missing information, preparing 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 conveying risks through labeling means such as Summary of Product Characteristics (SmPC) and patient information leaflets (PIL)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports, as well as regulatory agency website monitoring
  • Provide recommendations from signal assessments, including risk minimization approaches
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + QPPV Services in Jordan
  • Authoring and reviewing PSMF , PV SOPs, etc.
  • Review and sign-off of aggregate reports, signal reports, and RMPs
  • Retainer services for QPPV Services and Deputy
  • Monthly reconciliation
  • Medical review of signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly communication reports/provision of compliance metrics
  • PV Quality Management System Oversight
• + PV Audit & Compliance
  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs, and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authorities
  • Conduct regular gap assessments of PV staff at site locations
  • Provide organizational training on safety audits and inspections