Ranked #1 Drug Safety Physician Course Training Institute in India

CareerInPharma Diploma in Drug Safety Physician 

As a leading Drug Safety Physician training institute in Bangalore, CareerInPharma has been recognized as the ‘Best Clinical Research Training Institute 2024’ by top industry organizations. Our comprehensive online drug safety and pharmacovigilance training programs equip students with practical knowledge and industry-relevant skills, addressing the growing need for trained DSP/Medical Reviewer professionals in the evolving global market. CareerInPharma offers one of the best Drug Safety Physician (Medical Reviewer) courses in India, ensuring 100% placement assistance through unlimited placement calls. With the rising demand for skilled Medical Reviewer professionals, CareerInPharma provides an industry-focused online Drug Safety Physician (Medical Reviewer) Certificate Program, preparing candidates for careers in medical review, safety signals, risk management, GVP, regulatory compliance, and ICSR within the pharmaceutical and healthcare sectors.

Our industry-aligned curriculum is designed to provide a comprehensive understanding of Drug Safety Physician (Medical Reviewer), covering essential topics such as Adverse Event (AE) and Adverse Drug Reaction (ADR) Management, Individual Case Safety Reports (ICSRs) & Case Processing, Causality Assessment Methods, Signal Detection & Risk Management, Aggregate Reporting & Safety Documentation, Medical Review & Benefit-Risk Assessment, Safety Databases & Tools (ARGUS, ArisG, VigiBase, EudraVigilance), Good Pharmacovigilance Practices (GVP) & Global Regulations, Narrative Writing and MedDRA Coding, Risk Management Plans (RMP) and REMS. This structured approach ensures that students acquire practical skills and industry-relevant knowledge, preparing them for successful careers in pharmaceutical and healthcare industries. Our trainers are industry experts with extensive experience, providing practical insights into the workings of Clinical Research organizations (CROs), pharmaceutical companies, and regulatory bodies. At CareerInPharma, our dedicated placement team provides end-to-end career support, including interview preparation, personalized career guidance, and direct interview opportunities with top pharmaceutical and Contract Research organizations. With a proven track record, we have successfully placed over 200 candidates in leading companies, making CareerInPharma the preferred choice for aspiring Drug safety Physician professionals.

What is a Drug Safety Physician (Medical Reviewer)?

A Drug Safety Physician is a medical professional responsible for evaluating and ensuring the safety of pharmaceutical products. They play a crucial role in pharmacovigilance by reviewing and analyzing safety data from clinical trials and post-marketing sources. Their primary responsibility is to monitor and manage the benefit-risk profile of drugs, ensuring that potential safety concerns are identified and addressed promptly. They assess adverse event reports, investigate safety signals, and contribute to risk management strategies to maintain drug safety and effectiveness.

Drug Safety Physicians are responsible for preparing and reviewing regulatory documents such as Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans (RMPs), and regulatory inquiries. They ensure compliance with international regulatory standards, including ICH-GCP, FDA, European Pharmacovigilance legislation, and CIOMS. Their expertise is essential in case processing, signal detection, and risk mitigation, making them a key part of the pharmacovigilance and drug safety framework.

Why you should enrol in this course?

The pharmaceutical and healthcare industries are rapidly expanding, creating a high demand for skilled professionals in drug safety and pharmacovigilance. With the increasing number of clinical trials and the growing emphasis on patient safety, the role of a Drug Safety Physician (Medical Reviewer) has become more crucial than ever. Pharmaceutical companies, Contract Research Organizations (CROs), and regulatory agencies seek qualified professionals to assess drug safety, monitor adverse events, and ensure compliance with international regulations like ICH-GCP, FDA, and European Pharmacovigilance legislation.

The global pharmacovigilance market is projected to reach USD 20.64 billion by 2033, offering lucrative career opportunities in drug safety, risk management, and regulatory affairs. This course equips you with expertise in case processing, signal detection, safety data analysis, and medical reviews, preparing you for high-paying roles in top pharmaceutical companies, CROs, and regulatory bodies. By enrolling in this program, you will gain the specialized knowledge and practical skills needed to excel as a Drug Safety Physician, ensuring safer medications and better healthcare outcomes worldwide.

Who Should Apply for the Course?

Candidates should have a minimum of 55% in his/her graduation.

 Any UG/PG degree in Medical Doctor (MBBS)

(Non-MCI also eligible)

Focus of the Program

• Understanding the fundamentals of pharmacovigilance, including its role in drug safety and patient care.
• The drug development process and clinical trial phases, including BA/BE studies and regulatory approvals.
• Key regulatory frameworks such as ICH GCP, IRBs, and ethics committees.
• Adverse drug reactions (ADRs), adverse events (AEs), and serious adverse events (SAEs), along with their classification and management.
• The importance of informed consent and protocol adherence in clinical research.
• Causality assessment techniques, including dechallenge and rechallenge methods.
• Signal detection, risk management, and reporting of safety concerns in pharmacovigilance.
• Case processing methodologies, including data entry, narrative writing, and MedDRA coding.

Skills You Will Learn

• Expertise in clinical trial processes, ethical considerations, and regulatory frameworks.
• Mastery of adverse event reporting, case processing, and medical narrative writing.
• Proficiency in safety databases like ARGUS and ArisG for data entry and report generation.
• Hands-on experience with signal detection methods and risk management planning.
• Knowledge of different pharmacovigilance reports, including ICSRs, PSURs, and DSURs.
• Understanding of medical coding systems like MedDRA and WHO-DD.
• Strong communication skills for regulatory submissions, audits, and compliance reporting.
• Preparation for pharmacovigilance job interviews with essential Q&A guidance.

How To Apply Online?

Candidates can easily apply for The Drug Safety Physician Certification Course directly through our website. Once your application is received, our team will assist you with the next steps.

Alternatively, you can contact our admission officers directly:
📞 Call Us: +91 7022425292
💬 WhatsApp: +91 8971994549