Graduate Certificate in Global Pharmacovigilance Benefit-Risk Management

The Global Pharmacovigilance Benefit-Risk Assessment Graduate Certificate in the School of Pharmacy at Temple University provides the necessary training in the detection, assessment, understanding and prevention of adverse effects associated with the use of healthcare products. In the healthcare industry, it is the goal to move products through all phases of development in a timely and cost-efficient manner while also emphasizing and prioritizing public safety. This program prepares professionals for roles in drug safety.

This certificate is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program. Courses are offered in the evenings and on weekends for working professionals and can be offered virtually to corporate sites. Over 60 courses are offered online in real time. 

What is pharmacovigilance?

The discipline of pharmacovigilance is the practice of drug safety. It is the process of carrying out the observation of the effects of medical drugs once they have been licensed in order to identify and evaluate any adverse responses to these drugs.

Why study pharmacovigilance in the School of Pharmacy at Temple? 

The discipline of pharmacovigilance is constantly evolving in a dynamic regulatory, economic and scientific environment. The Global Pharmacovigilance Benefit-Risk Assessment Certificate provides a strong foundation in pharmacovigilance principles to both experienced professionals and those seeking entry into this career field from within and outside of regulated industry. Its five courses explore pharmacovigilance in a global environment, combining key regulatory, scientific, demographic and analytical concepts that define the field. 

Career Opportunities in Pharmacovigilance

Upon completing the certificate, students will understand and be prepared for careers involving safety oversight in the healthcare industry throughout the product life cycle. They will form expertise in reviewing safety profiles and managing as well as assessing the benefits and risks that arise during and after product development. 

Global Pharmacovigilance Benefit-Risk Management Learning Outcomes 

Through the curriculum, students will form a deep understanding of the following.  

• The need for pharmacovigilance regulations.

• The evolution of pharmacovigilance regulations.

• The domestic and international pharmacovigilance requirements and regulations for healthcare products.

• The differences in regulations between product types and regions.

• Pharmacovigilance data throughout product lifecycles.

• How to contextualize and interpret safety data.

• Common pharmacovigilance terminology and key stakeholders.

• Pharmacovigilance quality management systems and preparation for pharmacovigilance inspections. 

Regulatory Affairs and Quality Assurance at the School of Pharmacy 

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA. Regulatory affairs and quality assurance are the practices through which professionals ensure that products comply with government regulations and meet industry standards.

The School of Pharmacy  

• pioneered RA and QA graduate education in 1968, offered the first RA and QA online degree program, and offers the most comprehensive RA and QA curriculum;   

• has outstanding expert faculty from industry and the U.S. Food and Drug Administration, assuring the latest developments and practices are taught; 

• attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare); 

• schedules live courses with interactive discussions and workshops on evenings and weekends; 

• has hundreds of students from across the country, facilitating great networking opportunities; and 

• provides individualized services to students.    

Certificates provide credentials from Temple’s well-respected RA and QA graduate program, which can be applied to the RA and QA master’s degree. 

Program Format & Curriculum 

The Global Pharmacovigilance: Benefit-Risk Assessment Certificate may be earned on its own or on the way to the MS in RAQA. To earn the certificate, the following five courses must be successfully completed within a four-year period with an overall B (3.0 average).

• Good Pharmacovigilance Operations
• Pharmacoepidemiology
• Post-Marketing Safety Surveillance or Clinical Drug Safety and Pharmacovigilance
• The Regulatory and Legal Basis of Pharmacovigilance
• Risk Management and Safety Signaling of Healthcare Products 

All courses must be completed from Temple University’s RAQA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, the student may petition the RAQA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

Learn more about the Global Pharmacovigilance Benefit-Risk Assessment Certificate.

See the curriculum.

Requirements 

• Participants must have a bachelor’s degree from an accredited institution of higher learning. While no specific major is required, most applicants should have a background in healthcare, natural science, biological sciences or related disciplines.

• All courses must be completed from Temple University’s RAQA graduate program. No transfer credits from other institutions are accepted.

• Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and notice of completion).

• Only one certificate may be completed before students receive the MS.

• Students should complete the required courses for the certificate within four years. Students must apply for the certificate within one year of completing all required coursework for the program.

• Students interested in pursuing the RAQA MS program may apply all credits earned from the Global Pharmacovigilance: Benefit-Risk Assessment Certificate toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school. 

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more. You can view the full cost of attendance breakdown on the Student Financial Services website.