Why Pharmacovigilance?

Pharmacovigilance (PV) is the science of detecting, assessing, understanding, and preventing adverse effects of medicines. With the global PV market valued at over $5 billion, pharmaceutical companies, CROs, and regulatory agencies are in constant search of trained professionals.

Whether you are a pharmacy graduate, life sciences student, medical professional, or career switcher, this program gives you the technical expertise, hands-on practice, and certification you need to secure high-paying roles in the drug safety industry.

About RegAffair

RegAffair is a trusted name in pharmacovigilance and regulatory affairs training. Our curriculum is built by industry veterans, aligned with global standards, and enriched with real-world case studies.

• Practical database training
• Industry-relevant case handling
• Resume building & interview preparation
• Career guidance for global PV opportunities

Course Highlights

What You Will Learn

1. Introduction to Pharmacovigilance – Scope, need, and importance of PV; Roles and responsibilities in the PV industry.
2. Global Regulatory Framework – ICH E2E Guidelines, Good Pharmacovigilance Practices (GVP), FDA, EMA, CDSCO regulations.
3. Case Processing – AE reporting process, MedDRA coding, narrative writing, quality review.
4. Safety Databases – Hands-on training with Oracle Argus Safety: Case creation, workflow, reporting.
5. Signal Detection & Risk Management – Identifying safety signals, preparing Risk Management Plans (RMPs), regulatory submissions.

Benefits Over Non-Certified Candidates

• Priority in Hiring: Certified professionals are shortlisted faster by recruiters.
• Higher Salary Packages: Certified PV associates earn 20–30% more.
• Global Recognition: Certification valid across India, Gulf, Europe, US.
• Proven Competency: Employers trust certified candidates to be job-ready.
• Faster Career Growth: Move from entry to mid-level roles faster.
• Confidence in Interviews: Practical training ensures readiness.

Career Opportunities

Graduates are prepared for roles such as:

Average Starting Salary: ₹4–6 LPA (India) | $50k–$80k (Abroad)

Why Choose RegAffair?