SIGNAL DETECTION & RISK MANAGEMENT

Signal Detection & Risk Management

At Qtech-Sol, our Signal Detection & Risk Management (SDRM) program is designed for professionals seeking mastery over the proactive side of pharmacovigilance: identifying drug safety risks early, evaluating them rigorously, and implementing risk minimization strategies. With growing regulatory expectations and richer post-marketing safety data, organizations must be able not just to report adverse events, but to detect signals, assess risks, and manage them throughout the product lifecycle. SDRM gives you both the theoretical foundation and hands-on skills to handle this critical domain with confidence.

SIP – Self-Paced Online with Support

1. Course Duration: 3 weeks (80 hours)
2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).

   By the end of this course, learners will:

2. Understand what constitutes a signal in drug safety — how new or changing risks are detected.
3. Apply both qualitative and quantitative methods for signal detection (e.g. spontaneous reports, disproportionality analysis, data mining, statistical thresholds).
4. Validate, triage, and prioritize detected signals based on clinical plausibility, severity, frequency, and regulatory importance.
5. Conduct robust risk assessment and risk management planning (RMPs), including identification of risk-minimization measures.
6. Understand regulatory expectations (e.g. EU GVP Module IX, FDA guidance) for signal detection, signal management, and risk communication.
7. Use real-world data sources (ICSRs, literature, electronic health records, case reports) in detecting and evaluating signals.
8. Communicate findings effectively: preparing internal reports, regulatory submissions, safety updates, and product label changes.

This course is ideal for:

1. Drug Safety / Pharmacovigilance Associates or Specialists looking to deepen their skills in signal detection & risk management
2. Regulatory Affairs staff involved with safety reporting or risk mitigation
3. Clinical Research Professionals interested in transitioning to safety/science roles
4. Healthcare / Safety Science professionals involved in post-marketing surveillance

Learners should have foundational knowledge of pharmacovigilance (AEs, SAEs, signal vs noise), understanding of basic clinical research / drug development processes, comfort with data handling / basic statistics, and strong written communication skills.

1. Gain practical competency in detecting, validating, and managing safety signals.
2. Be able to support or lead preparation of RMPs and regulatory risk communication.
3. Improve career readiness for PV roles such as Signal Management Specialist, Drug Safety Scientist, Regulatory Affairs Associate, or PV Lead.
4. Enhance your ability to contribute proactively to patient safety and regulatory compliance.

This program is aligned with:

1. EMA GVP Module IX – Signal Management European Medicines Agency (EMA)
2. CIOMS Working Group VIII, which outlines practical strategies for signal detection, prioritization, evaluation, and risk management CIOMS
3. Guidance on signal detection & management from regulatory authorities (FDA, EMA) Pharmaceutical Press+1

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.