Post-Marketing Monitoring

Post-Marketing Monitoring: Master Pharmacovigilance and Drug Safety Surveillance

Once a medicine is approved, the responsibility for patient safety only intensifies. This certified learning path, developed under the expert guidance of Dr. Patricia Kay, equips pharmacovigilance professionals, medical affairs teams, and regulatory specialists with the end-to-end capabilities needed to monitor, assess, and report on drug safety in the post-marketing environment — in full compliance with EMA, FDA, and ICH requirements.

Course Breakdown:

• Good Pharmacovigilance Practice (GVP): Master the EMA’s GVP modules framework — the regulatory foundation governing all post-marketing safety activities for medicinal products authorised in the EU.
• Serious Adverse Event Reporting & Case Processing: Learn the end-to-end process for identifying, assessing, documenting, and submitting serious adverse event reports within regulatory timelines.
• Signal Detection and Management in Pharmacovigilance: Apply quantitative and qualitative signal detection methods to identify potential safety concerns from spontaneous reports, literature, and clinical data sources.
• Medical Writing of Periodic Benefit-Risk Evaluation Report (PBRER): Build the skills to author and review PBRERs — the key periodic safety report required by ICH E2C(R2) and submitted to global regulatory authorities.
• Management of Periodic Safety Update Reports (PSURs): Understand the structure, content requirements, and submission timelines of PSURs across EU and international regulatory frameworks.
• Pharmacovigilance Case Handling: Develop practical case processing skills — from case intake and narrative writing to medical coding and submission of individual case safety reports (ICSRs).
• Global Pharmacovigilance Awareness: Broaden your understanding of pharmacovigilance systems, obligations, and regulatory expectations across major global markets including EU, US, and ICH regions.

Why Choose This Learning Path?

• Expert-Led Curriculum: Developed by Dr. Patricia Kay, a senior life sciences professional with over 20 years of experience spanning clinical development, safety management, and regulatory strategy.
• Comprehensive Coverage: From GVP foundations and SAE reporting through signal detection, PBRER authoring, and global PV awareness, this path covers every pillar of post-marketing safety surveillance.
• Flexible Learning: Fully self-paced and online — designed for professionals managing active pharmacovigilance responsibilities.
• Certification: Earn a recognised certificate demonstrating your post-marketing pharmacovigilance competency to employers, sponsors, and regulators.

Who Should Enroll?

Whether you are a pharmacovigilance officer, drug safety scientist, medical affairs professional, or regulatory specialist responsible for post-marketing safety obligations, this path was built for you. It is equally valuable for pharmaceutical and biotech companies building or strengthening their pharmacovigilance function.

Protect Patients. Fulfil Your Regulatory Obligations. Advance Your Career.

Join thousands of life sciences professionals who have used GxP Training to earn recognised certifications. In a landscape of increasing regulatory scrutiny and global pharmacovigilance harmonisation, post-marketing expertise is one of the most in-demand skill sets in the industry. Enroll today.