Comprehensive Post-Marketing Pharmacovigilance for
Ongoing Product Safety
Ongoing Product Safety
Post-marketing pharmacovigilance (PV) is the foundation of drug safety, ensuring continuous monitoring of your product after market introduction. A robust post-marketing PV system helps detect, assess, and mitigate potential risks while ensuring regulatory compliance and patient safety. Our expertise supports ongoing safety surveillance, risk management, and regulatory reporting, providing you with the confidence to maintain product integrity and compliance throughout its lifecycle.
Our Post Marketing Pharmacovigilance leads
Seema Jaitly
Pharmacovigilance Physician
Bill Richardson
Pharmacovigilance Physician
Bridget King
Pharmacovigilance Consultant, Risk Management
Shelley Forword
PV Consultant, QPPV/LSO Management & PV Systems
Varsha Vasi
Pharmacovigilance Physician
Our Post-Marketing Pharmacovigilance Services
Safety Data Collection & Case Management
- ICSR Processing & Medical Review – Ensuring accurate and timely reporting of adverse events.
- Literature Review – Screening global scientific literature for safety signals and regulatory reporting.
- XEVMPD/EV/MedDRA Maintenance – Managing safety databases and regulatory compliance.
Signal Detection & Risk Management
- Signal Detection & Management – Proactive identification, assessment, and mitigation of emerging safety signals.
- Epidemiology & RWE Analysis – Supporting signal evaluation and benefit-risk assessment through real-world data insights.
- Health Authority Signal Requests – Responding to regulatory inquiries and signal validation requests.
- Risk Management Plan (RMP) & REMs Maintenance – Ensuring ongoing compliance and updates for risk management.
- Monitoring & Effectiveness of Additional RMMs – Evaluating risk minimisation strategies for continued effectiveness.
- Benefit-Risk Assessments – Conducting periodic evaluations to support decision-making.
Regulatory Reporting & Compliance
- Aggregate Reports (PADERs, PSURs, Signal Assessments) – Preparation and submission of periodic safety reports.
- Post-Authorisation Safety Studies (PASS) – Advising on PASS to meet regulatory requirements.
- Safety Communication (DHPCs) – Developing direct healthcare professional communications (DHPCs).
- Safety Variations & Reclassifications – Managing regulatory submissions for safety-related updates.
Ongoing Oversight & Lifecycle Management
- Lifecycle Management into Clinical Trials (CTs) – Ensuring smooth transition of post-marketing safety data into ongoing clinical trials.
- Protocol Review, Progress Reports & Interim Safety Reviews – Providing continuous support for safety study oversight.
- Ongoing Vendor Management & Oversight – Ensuring compliance and quality in outsourced PV functions.
