Pharmacovigilance services in Singapore

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Singapore, access to tailored Pharmacovigilance Services in Singapore is essential for ensuring drug safety and regulatory compliance. From adverse-drug-reaction reporting to post-marketing surveillance, the right local pharmacovigilance partner Singapore shapes everything, from signal detection and risk-management planning to safety reporting and successful product lifecycle management.

Expert Pharmacovigilance Services for the Singapore Market

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Singapore, access to tailored Pharmacovigilance Services in Singapore is essential for ensuring drug safety and regulatory compliance. From adverse-drug-reaction reporting to post-marketing surveillance, the right local pharmacovigilance partner Singapore shapes everything, from signal detection and risk-management planning to safety reporting and successful product lifecycle management.

Under this system:

• Mandatory reporting of all serious adverse events by pharmaceutical companies is required using the CIOMS I form, submitted via online reporting or to the VCB.
• Healthcare professionals (HCPs) and consumers are encouraged to report adverse drug reactions online or via manual, colour-coded forms (yellow for drugs, blue for vaccines, green for advanced therapies).
• Risk Management Plans (RMPs ) are mandatory for NDA-1 and biosimilar applications and may be requested depending on the product type; submissions must include a Singapore-specific annex alongside reference RMPs or REMS.
• Periodic Benefit-Risk Evaluation Reports (PBRERs ) must be submitted at specified intervals: every 6 months for two years, then annually for up to three more years.
• HSA also provides post-marketing vigilance guidance, including recent updates such as removal of RMP submission requirement for biosimilars and requirements for routine PV and risk minimisation activities.

Why Choose DDReg as Your Pharmacovigilance Local Partner in Singapore?

As a leading pharmacovigilance consulting firm , DDReg understands that patient safety spans from clinical trials to post-marketing surveillance. We offer comprehensive PV services in Singapore tailored to uphold compliance with HSA regulations and global standards. Our pharmacovigilance solutions Singapore include:

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases and other relevant databases integrated with drug dictionaries (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 (RMP)
  • Drafting, reviewing, and maintaining Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies ( 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 preparation of 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 labeling documents – i.e., Prescribing Information & Medical Guides (PIL)
• + Aggregate Reports
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new or changing safety signals from ICSRs, literature, PBRERs, and regulatory websites
  • Use of in-house tools for signal detection and tracking
  • Signal review, label update analysis, and recommendations
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + PV Services & Oversight
  • Authoring and reviewing PSMF, SDEA agreements, PV SOPs, and partner agreements
  • Monthly reconciliations and medical reviews
  • Organized Signal Surveillance Meetings (quarterly)
  • Monthly compliance metrics and communication reports
• + PV Audit & Compliance
  • Compliance audits against PV guidelines, regulations, SDEAs, SOPs, and work instructions
  • Development of audit plans and mock audits to prepare for HSA inspections
  • Gap assessments of PV teams on-site
  • Organizational training on safety audits and inspection readiness