Global Pharmacovigilance: Benefit-Risk Management Post-Master’s Certificate

Master the science of drug safety by collecting, detecting, assessing, monitoring, and preventing adverse effects of medical drugs with the Global Pharmacovigilance: Benefit-Risk Management Post-Master’s Certificate in the School of Pharmacy of Temple University. This is a 15-credit graduate certificate for entry-level and working professionals who want a robust framework of pharmacovigilance principles—from exploring it in a global environment, to combining key regulatory, scientific, demographic, and analytical ideas that define the field. Students who participate in the Global Pharmacovigilance: Benefit Risk-Management Post-Master’s Certificate have earned a M.S. degree in RAQA from Temple or a comparable graduate program.

For working professionals, courses are conveniently scheduled on evenings and weekends and can be videoconferenced to corporate sites. Online instruction is also available. Classes are hosted on Temple’s Fort Washington Campus, approximately 20 miles from the university’s Health Sciences Center. This is the first academic certificate in pharmacovigilance, making it an exciting step for students and professionals looking to expand their knowledge on such a complex subject.

Since the field is a quantitative discipline, students will gain a grasp of interpreting data objectively and scientifically. Basic statistical principles will be reviewed such as epidemiology concepts of ratios and rates, quantitative measures of benefit, and exposure estimation. Through numerous discussions and lectures, students will have a well-rounded knowledge of the pharmacovigilance field, including but not limited to risk management, safety signaling of healthcare products, pharmacoepidemiology, acceptable operations, and a historical overview of both American (FDA) and international (ICH-E2C) regulatory requirements for drug pharmacovigilance or post-marketing safety surveillance techniques. 

Classes & Curriculum 

The post-master’s certificate consists of five courses, in addition to completing the M.S. degree in RAQA (or a comparable master’s degree program):

  • Post-Marketing Safety Surveillance (5571) or Clinical Drug Safety and Pharmacovigilance (5538)
  • Good Pharmacovigilance Operations (5508)
  • Pharmacoepidemiology (5573)
  • Regulatory and Legal Basis of Pharmacovigilance (5579)
  • Risk Management and Safety Signaling Healthcare Products (5578)

This certificate equates to 15 credits and should be completed within four years.

Careers

Career Opportunities RAQA

Alumni and current students of the Regulatory Affairs and Quality Assurance graduate program can join the job postings listserv to gain access to current career opportunities.

Career Night RAQA

Regulatory Affairs and Quality Assurance hosts an annual career night for students to meet at least a dozen actively hiring companies. The evening features presentations on topics for breaking into the industry and gaining employment, such as interviewing tips and resume writing.

Students are also encouraged to speak with Regulatory Affairs and Quality Assurance faculty about their professional goals and ambitions.

PH-GPBR-GRPM

Additional Program Information

Available online.