Global Pharmacovigilance

Available at Pre- and Post-Master’s Levels

Pre-Master’s Certificate in Global Pharmacovigilance: Benefit-Risk Assessment

The pharmaceutical industry is challenged with providing oversight of a drug’s safety throughout the product lifecycle. Reviewing safety profiles and managing and assessing benefit and risk that arise during and after drug development are constant concerns. This certificate provides a foundation in pharmacovigilance principles to both experienced professionals and those seeking entry into this career field from within and outside the pharmaceutical area.

This five-course program provides a solid scientific and regulatory foundation in the key disciplines necessary for a successful career in the field.

The required courses include:

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

Students have four years to complete the Certificate in Global Pharmacovigilance:  Benefit-Risk Assessment and must maintain an overall B average.

Brochure
Application Form
Notice of Completion

Post-Master’s Certificate in Global Pharmacovigilance: Benefit-Risk Assessment

Students who have received the M.S. are eligible to complete the Post-Master’s Certificate in Global Pharmacovigilance: Benefit-Risk Assessment. Courses taken for the completion of the M.S. degree will not be counted towards the Post-Master’s Certificate in Global Pharmacovigilance: Benefit-Risk Assessment. Students need to take five additional courses beyond the M.S. to receive the additional certificate in Global Pharmacovigilance: Benefit-Risk Assessment. Only the following courses may be taken towards completion of this program:

  • Post-Marketing Safety Surveillance (Pharmaceutics 5571) OR Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538) (Only one may count).
  • Good Pharmacovigilance Operations (Pharmaceutics 5508)
  • Pharmacoepidemiology (Pharmaceutics 5573)
  • Regulatory and Legal Basis of Pharmacovigilance (Pharmaceutics 5579)
  • Risk Management and Safety Signaling of Healthcare Products (Pharmaceutics 5578)

If a graduate of the Temple QA/RA program has already taken one or more of the above courses as part of their M.S. program and still wishes to pursue the Post-Master's Certificate in Pharmacovigilance, they may petition the Assistant Dean to substitute a course related to the field, including

  • Global Clinical Drug Development (Pharmaceutics 5539)
  • Project Management for Clinical Trials (Pharmaceutics 5547)
  • Clinical Data Management (Pharmaceutics 5618)
  • Statistics for Clinical Trials (Pharmaceutics 5497)

The request for a substitute must be made - and approved - in advance of pursuing the Certificate.

Brochure
Application
Post-M.S. Notice of Completion

This certificate is open to students who received their master's degrees from other schools.  These individuals must take the following five courses for its completion:

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