Post-Marketing Monitoring

Post-Marketing Monitoring Training: Master Pharmacovigilance and Drug Safety Surveillance

A single unmanaged safety signal can trigger a product recall, regulatory action, and catastrophic loss of patient trust. This certified online learning path in post-marketing monitoring, developed under the expert guidance of Dr. Patricia Kay, equips pharmacovigilance officers, drug safety scientists, and medical affairs professionals with the end-to-end tools to detect, assess, and report on drug safety in full compliance with EMA GVP, FDA, and ICH requirements.

Course Breakdown:

• Good Pharmacovigilance Practice (GVP): Master the EMA GVP modules, the regulatory foundation governing post-marketing safety activities for medicinal products authorized in the EU.
• Serious Adverse Event Reporting & Case Processing: Learn the process for identifying, assessing, documenting, and submitting SAE reports within regulatory timelines.
• Signal Detection and Management in Pharmacovigilance: Apply quantitative and qualitative signal detection methods to surface safety concerns from spontaneous reports, literature, and clinical data.
• Medical Writing of Periodic Benefit-Risk Evaluation Report (PBRER): 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 frameworks.
• Pharmacovigilance Case Handling: Build practical case processing skills, from intake and narrative writing to medical coding and ICSR submission.
• Global Pharmacovigilance Awareness: Broaden your understanding of PV systems, obligations, and regulatory expectations across EU, US, and ICH regions.

Why Choose This Learning Path?

• Expert-Led Curriculum: Developed by Dr. Patricia Kay, a senior life sciences leader with 20+ years across clinical development, safety management, and regulatory strategy.
• End-to-End Coverage: From GVP foundations and SAE reporting through signal detection, PBRER authoring, and global PV awareness, every pillar of post-marketing safety in one path.
• Flexible Learning: Fully self-paced and online. Designed for professionals managing active pharmacovigilance responsibilities.
• Recognized Certification: Earn a CPD/CEU-accredited, 21 CFR Part 11-compliant certificate demonstrating your post-marketing PV competency to employers, sponsors, and regulators.

What You’ll Be Able to Do

• Operate in full compliance with EMA GVP and FDA post-marketing safety requirements.
• Process SAE and ICSR cases within regulatory timelines.
• Run quantitative and qualitative signal detection on post-marketing data.
• Author and review PBRER and PSUR submissions.

Who Should Enroll?

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

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

GxP Training delivers certified, employer-recognized training to life sciences professionals worldwide. In a landscape of increasing regulatory scrutiny and global PV harmonization, post-marketing expertise is one of the most in-demand skill sets in the industry. Enroll today.