Pharmacovigilance Services

What we do: PKCS designs, implements, and operates pharmacovigilance (PV) systems for marketing authorization holders across Iraq, the UAE, Saudi Arabia, and the wider GCC. We provide qualified person responsible for pharmacovigilance (QPPV) services, individual case safety report (ICSR) handling, periodic safety update reports (PSUR/PBRER), signal management, and PV system master files compliant with regional authority expectations.

Why pharmacovigilance matters for MENA market access

Every marketing authorization holder is legally accountable for the safety profile of its product after launch. Iraq, the UAE, and Saudi Arabia each operate their own pharmacovigilance reporting frameworks — and each requires a named local responsible person, defined reporting timelines for adverse events, periodic safety reports, and the ability to act on emerging safety signals. The Saudi National Pharmacovigilance Center (NPC) under SFDA, the UAE Pharmacovigilance system under MOHAP, and the Iraq MOH PV system each have their own portals, languages, and timelines.

Pharmacovigilance is not optional. Failure to report serious adverse events within the regulatory deadline, or absence of a qualifying QPPV where one is required, leads to enforcement action — withdrawal of marketing authorization, market suspension, or refusal of new submissions. PKCS keeps clients on the right side of every regional reporting deadline.

What does PKCS deliver as a pharmacovigilance partner?

• QPPV provision — A named, qualified pharmacovigilance officer with the regional regulatory standing required by MOHAP, SFDA, and other GCC authorities.
• ICSR processing — Receipt, triage, MedDRA coding, narrative writing, and submission of individual case safety reports within the regional deadlines (15 days for serious, 90 days for non-serious in most regional regimes).
• PSUR/PBRER preparation and submission — Periodic safety reporting in the format and cadence each authority expects.
• Signal management — Ongoing review of cumulative case data for emerging safety signals.
• Pharmacovigilance System Master File (PSMF) — Drafting, maintenance, and inspection-readiness of the PSMF.
• Risk Management Plans (RMPs) — Adaptation of EU-style RMPs for regional authorities, including additional risk minimization activities where required.
• Audits and inspection support — PV system audits, mock inspections, and on-the-day inspection support.

Which authorities does PKCS report to?

PKCS submits adverse event reports and periodic safety reports through the appropriate regional channels: the Saudi National Pharmacovigilance Center (NPC) and the SFDA reporting portal; the UAE pharmacovigilance system operated under MOHAP and the Emirates Drug Establishment; the Iraq MOH pharmacovigilance unit; the Egyptian Drug Authority (EDA) PV department; and the Jordan FDA. For multi-country marketing authorizations, PKCS coordinates a single source-of-truth case database and routes reports to each authority on its required timeline.

How does pharmacovigilance integrate with regulatory affairs?

Pharmacovigilance is a continuous obligation that begins the moment a product is approved. PKCS clients who use both regulatory affairs and pharmacovigilance services benefit from a single team that understands the product’s full regulatory history — meaning faster lifecycle changes, cleaner variations, and tighter coordination between submitting authorities and the safety team.

Related services

• Regulatory Affairs — End-to-end dossier preparation and lifecycle management.
• Quality Systems & GMP — GMP compliance and audit support for manufacturing operations.
• Saudi SFDA Registration — SFDA-specific PV requirements and NPC reporting.

Frequently asked questions

Does PKCS provide a QPPV for Saudi Arabia and the UAE?

Yes. PKCS provides a named QPPV who meets the qualification requirements of SFDA (NPC) and MOHAP/EDE, and who is the registered point of contact for the relevant authority.

What are the reporting timelines for adverse events in the GCC?

Most regional regimes follow ICH E2D timelines: serious adverse drug reactions reported within 15 calendar days, non-serious within 90 days. Specific country deviations are accommodated in the PV system PKCS implements.

Can PKCS take over an existing pharmacovigilance system mid-cycle?

Yes. PKCS regularly takes over PV operations from outgoing providers — including PSMF transfer, case database migration, regulatory authority notifications, and continuity of QPPV coverage.

Do you support pharmacovigilance audits and inspections?

Yes. PKCS conducts internal PV audits, prepares clients for SFDA and MOHAP PV inspections, and provides on-the-day inspection support.