Online Master's Degree in Pharmacovigilance and Regulatory Affairs
DURATION
1 Years
LANGUAGES
Spanish
PACE
Full time
APPLICATION DEADLINE
Request application deadline
EARLIEST START DATE
Sep 2025
TUITION FEES
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STUDY FORMAT
Distance Learning
Introduction
The pharmaceutical sector is a sector that is heavily regulated by the Health Authorities in order to protect the health of patients as much as possible and no medicine can be marketed without prior authorization.
The Regulatory Affairs and Pharmacovigilance departments are the main interlocutors of pharmaceutical companies with health authorities both at national and international level.
The online Master's Degree in Pharmacovigilance and Regulatory Affairs is designed to train highly qualified professionals in the field of pharmaceutical regulation, in relations with health authorities in the field of medicines and other legal bases such as medical devices, cosmetics and food supplements.
In addition, it provides in -depth knowledge in the field of pharmacovigilance and safety of clinical trials in order to meet the challenges of the sector with a rigorous and up-to-date approach.
The student will develop a solid specialization and advance his or her professional career in this highly relevant field of public health.
Admissions
Curriculum
- Overview of the pharmaceutical industry
- Introduction to pharmacovigilance of medicines and other pharmaceutical products
- Management and handling of suspected adverse reactions
- Clinical research with drugs
- Aggregate security and signal detection reports
- Quality in pharmacovigilance
- Structure of health authorities involved in drug registration
- Registration dossier.
- Post-authorization regulatory procedures
- Cosmetic products and personal care products
- Medical devices
- Food supplements and other products
Program Outcome
- Provide a comprehensive view of regulatory processes with Health Authorities.
- Manage adverse reactions in pharmacovigilance and ensure the safety of medicines in clinical trials.
- Thoroughly understand international regulations and procedures for marketing pharmaceutical products.
- Monitor medicines, ensuring their safe and rational use through continuous risk assessment.
- Evaluate the risk/benefit ratio throughout the life cycle of a medicine.
- Detect unidentified adverse reactions prior to marketing authorization.
Career Opportunities
The online Master's Degree in Pharmacovigilance and Regulatory Affairs allows students to develop a professional career in medical, pharmacovigilance and registration departments of pharmaceutical companies both nationally and internationally .
At a professional level, students will be in a position to occupy positions of responsibility both in the pharmaceutical industry and in health authorities and other official bodies, since the training is aimed at meeting the demand for specialized professionals in these sectors.
- Regulatory Affairs Manager.
- Head of Pharmacovigilance (Qualify Person for Pharmacovigilance).
- Pharmacovigilance Director (Pharmacovigilance Manager).
- Pharmacovigilance Technician (Drug Safety Officer)
- Records Technician (Regulatory Affairs Specialist).
- Evaluator at Regulatory Agencies.
- Regulatory Compliance Auditor.
- Regulatory Affairs Consultant.
- Head of Quality Assurance in Pharmacovigilance.
- Medical Affairs.
- Professor and Researcher in Regulatory Affairs and Pharmacovigilance.