Postgraduate Certificate in Drug Safety and Pharmacovigilance for Physicians - Job Ready Program Become a Drug Safety Physicians/Pharmacovigilance Professional in Four Months. Protect patients. Shape therapies. Extend your clinical impact beyond the bedside.

This program is designed for medical doctors (MBBS/MD) who want to build a rewarding non-clinical career in the pharma, healthcare, or IT industries. Pharmacovigilance (Drug Safety) is the science of detecting, assessing, and preventing side effects or medicine-related risks. Every global pharmaceutical company and CRO needs trained Drug Safety Physicians to ensure patient safety and regulatory compliance.

Through this program, doctors learn to apply their clinical knowledge in a corporate setting analyzing real-world safety cases, reviewing adverse events, and collaborating with global teams at leading companies.

Pharmacovigilance means keeping patients safe by monitoring medicines after they are launched.

PV Doctors review reports of side effects, evaluate if the medicine caused the event, and ensure the case is properly reported to global health authorities.

This rigorous, practice-oriented Postgraduate Certificate blends medical science with regulatory and industry practice in drug safety. Designed for working physicians, the program spans 4 months.

The course is made for doctors who want to do more than just diagnose. It is open for:

• For clinical researchers: Add formal safety expertise that improves trial oversight and SAE handling.

• For academic physicians: Enable safety-oriented research and pharmacoepidemiology collaborations.

• For those moving into industry: A credential showcasing medical competence in PV.

The course will take you from bedside to bench side. You'll master every pillar of drug safety. The curriculum below reflects this sentiment. Each module contains applied exercises and case studies drawn from real safety scenarios.

• Foundations of Pharmacovigilance

• Global Drug Safety regulations (ICH, GVP, CDSCO, FDA, EMA guidelines)

• Adverse Event & Serious Adverse Event (SAE) assessment

• Adverse Event Identification & Reporting (ICSRs)

• Clinical Causality Assessment & Medical Evaluation

• MedDRA & WHO-Drug coding principles

• Narrative writing and medical review

• Signal detection and risk-benefit evaluation

• Global case processing workflow in pharma & IT companies

• Signal Detection & Data Analytics

• Hands-on training with Oracle Argus Safety and ARISg software

• Risk Management & Benefit–Risk Assessment

• PV in Clinical Trials

Your medical degree is just the beginning. Graduates can move into multiple positions:

On completion, you will be able to:

• Interpret and write high-quality medical evaluations and causality opinions
• Create and quality-check ICSRs to regulatory standards
• Use MedDRA for accurate event coding and WHO Drug basics for medication coding
• Perform basic signal detection and convert data outputs into clinically meaningful insights
• Draft risk management plan elements and safety sections suitable for regulatory submissions
• Communicate safety risks to clinicians, patients, and regulators with clinical accuracy
• Navigate global reporting requirements, timelines, and inspection expectations