Post-Master's Certificate: Global Pharmacovigilance/Benefit-Risk Management

SCHOOL OF PHARMACY

About the Certificate

The post-master's certificate in Global Pharmacovigilance/Benefit-Risk Assessment is designed for those who hold an MS in Regulatory Affairs and Quality Assurance and want to keep current with industry issues and meet regulatory requirements for training. The certificate program is also open to professionals with other master's or doctoral degrees.

Pharmacovigilance is constantly evolving in a dynamic regulatory, economic and scientific environment. The post-master's certificate in Global Pharmacovigilance/Benefit-Risk Assessment provides a solid scientific and regulatory foundation in the key disciplines necessary for a successful career in the field of pharmacovigilance. It focuses on establishing a platform for continuous learning in pharmacovigilance rather than on an unrealistic goal of seeking total subject mastery. Importantly, it focuses on pharmacovigilance in a global environment.

Time Limit for Certificate Completion: 4 years

Campus Location: Fort Washington and Online

Full-Time/Part-Time Status: The certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.

Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.

Admission Requirements and Deadlines

Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.

APPLY HERE to the post-master's certificate program.

Master's Degree in Discipline/Related Discipline: Applicants must hold a master's degree in a Pharmacy-related field, including but not limited to an MS in Regulatory Affairs and Quality Assurance. Graduates of Temple University's RAQA program take certificate coursework to keep current with industry issues and meet regulatory requirements for training. Applicants with an advanced science degree from an accredited institution of higher learning other than Temple University must have worked in the pharmaceutical industry for a minimum of three years.

Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a bachelor's degree from an accredited institution. While no specific major is required, most applicants should have a background in biological sciences, engineering, healthcare, natural sciences or related disciplines.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 15

Required Courses:1

QARA 5508Good Pharmacovigilance Operations3
QARA 5538Clinical Drug Safety and Pharmacovigilance3
or QARA 5571 Post-Marketing Safety Surveillance
QARA 5573Pharmacoepidemiology3
QARA 5578Benefit Risk Management and Safety Signaling of Healthcare Products3
QARA 5579Regulatory and Legal Basis of Pharmacovigilance3
Total Credit Hours15

Approved QARA Courses for Substitution of Required Coursework Previously Completed

QARA 5539Global Clinical Drug Development3
QARA 5547Project Management for Clinical Trials3
QARA 5548Risk Management of Pharmaceutical and Medical Devices3
QARA 5612Bioethics for Pharmaceutical Professionals3

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://pharmacy.temple.edu/raqa/certificate-programs/post-masters-certificates/global-pharmacovigilance-benefit-risk-assessment

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

267-468-8560

Mailing Address for Application Materials:

Temple University

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

Wendy Lebing, MALD, MS

Program Coordinator

qara@temple.edu

267-468-8560