Pharmacovigilance Course

Pharmacovigilance Courses In Pune

100% job Guarantee | Arete Training Institute

Best Pharmacovigilance Course in Pune with 100% Placement Guarantee

Enroll in the top Pharmacovigilance courses in Pune, which offer a 100% job guarantee and include topics such as clinical data management, Clinical research, ICH-GCP, clinical trials, regulatory affairs, medical writing, drug development process, and more.

3 months

Duration

100%

Placement

Online+ Offline

Batches

150+

Placed Student

Why Arete Training Institute for
Pharmacovigilance Training

Arete provides a Pharmacovigilance course in Pune with a 100% placement guaruntee. The curriculum is designed to promote hands-on learning, solid foundations, and comprehension of real-world workflows. This helps you get ready to learn efficiently and perform with assurance in interviews and entry-level positions.
This Pharmacovigilance course in Pune covers the full Pharmacovigilance fundamentals. Clinical research, trial monitoring, clinical data management (CDM), pharmacovigilance (PV), regulatory affairs (RA), ICH-GCP (E6), drug development, and protocol design are all included. Expert-led seminars, case-based learning, weekly tests, presentations, simulated interviews, and placement assistance are all included in the course.

Pharmacovigilance Course Syllabus-2026

Argus Software Training

Get hands-on training on Oracle Argus Safety by Arete Training Institute — the world's most widely used pharmacovigilance database. Learn to process Individual Case Safety Reports (ICSRs) end-to-end, from case intake and data entry to follow-up and submission. Practice real-world adverse event scenarios in a live-format Argus environment, exactly as you would on the job at a CRO or pharma company. By the time you complete this module, you can confidently walk into any drug safety role that requires Oracle Argus proficiency.

Intro to Pharmacovigilance

At Arete Training Institute, our pharmacovigilance course in Pune gives you the knowledge, tools, and industry-readiness to build a rewarding career in drug safety. Pharmacovigilance is the science of monitoring medicines for safety after they reach patients — protecting lives long after a drug is approved. It involves the detection, assessment, and prevention of adverse drug reactions, making it a critical function within every pharmaceutical company and CRO worldwide. Regulatory agencies like the FDA, EMA, and CDSCO require all drug manufacturers to maintain active pharmacovigilance systems, creating a steady and growing demand for trained professionals.

Adverse Event

At Arete Training Institute, our adverse event training covers WHO's Type A-F ADR classification, causality assessment, and the minimum data requirements for a valid Individual Case Safety Report (ICSR). Students work through real-world case scenarios, learning to distinguish serious from non-serious events, apply MedDRA coding, and meet FDA, EMA, and CDSCO reporting timelines with confidence. With Arete's hands-on approach, you don't just understand adverse events — you learn to handle them exactly the way the industry demands

MedDRA

At Arete Training Institute, we take you through the complete five-level MedDRA hierarchy from System Organ Class (SOC) at the top down to the Lowest Level Term (LLT) where actual adverse event reports are coded. You learn not just the structure, but how to apply it: how to select the correct Preferred Term (PT) for a given case narrative, how to navigate multi-SOC terms, and how to avoid the most common coding errors that lead to regulatory queries. Every concept is reinforced with live adverse event case exercises, so you graduate with real coding speed and accuracy.

Guidelines-E2A, E2B, E2E

At Arete Training Institute, our ICH Guidelines training covers E2A, E2B, and E2E these three pillars that govern how adverse events are defined, reported, and managed across the global pharmaceutical industry. You learn not just what these guidelines say, but how to apply them in real drug safety operations, regulatory submissions, and pharmacovigilance planning.

GVP Definitions, Good PV practices

At Arete Training Institute, our GVP training covers all key definition ,QPPV, PSMF, MAH, RMP, and PBRER giving you a clear understanding of how a compliant pharmacovigilance system is structured and governed. You learn how EMA's Good Pharmacovigilance Practice modules apply in real industry roles, from ICSR submission and signal management to periodic safety reporting and Risk Management Plans.

Regulatory agencies FDA, MHRA, EMEA

At Arete Training Institute, our regulatory agencies module covers the FDA, MHRA, and EMA teaching you how adverse event reports are submitted to FAERS, the Yellow Card system, and EudraVigilance respectively, along with the specific timelines each agency mandates. You gain a practical understanding of how global pharma companies manage multi-agency pharmacovigilance obligations, giving you the regulatory awareness that employers look for in every drug safety role.

Serious Adverse events (SAE)

At Arete Training Institute, our SAE training covers all six serious adverse event criteria death, life-threatening conditions, hospitalisation, disability, congenital anomaly, and important medical events along with the critical distinction between 'serious' and 'severe' that every PV professional must know. You learn 7-day and 15-day expedited reporting rules, SUSAR identification, and end-to-end SAE processing exactly as it is practiced in global pharma companies and CROs