Division of Pharmacovigilance Program Description
Office of Surveillance and Epidemiology (OSE)/ Office of Pharmacovigilance and Epidemiology (OPE)
Divisions of Pharmacovigilance (I and II)
Goals and Objectives for Pharmacy Student Rotations
- To familiarize the student with the role of CDER, OSE, and DPV I-II in post-marketing safety.
- To assist DPV I-II in our mission to protect public health by detecting and analyzing postmarketing adverse event data to identify drug safety concerns and recommend actions to improve product safety.
- Learning Objectives. Upon completion of this rotation, the student will be able to:
- Explain the FDA’s mission, functions, and organizational structure, including the role of DPV I-II within the FDA.
- Discuss laws, regulations, and guidance documents related to post-marketing drug safety.
- Discuss basic principles of Pharmacoepidemiology and Pharmacovigilance
- Describe the origin of postmarketing reports in FDA Adverse Event Reporting System (FAERS) Database.
- Explain the roles and responsibilities of a post-marketing safety evaluator in DPV I-II within the FDA.
- Utilize available resources to identify and evaluate potential safety signals (e.g. FAERS, data mining, scientific literature, etc).
- Explain post-marketing surveillance mechanisms that OSE uses to identify drug safety concerns and recommend actions to improve product safety.
- Demonstrate acceptable qualities and characteristics of professional behavior in areas of confidentiality, communication, appearance, timeliness, commitment, and initiative.
- Student Requirements (may include, but not limited to)
- Given a preceptor-approved topic, provide a written summary and an oral presentation describing a postmarketing safety issue.
- Complete ancillary preceptor-approved assignments (e.g. journal club; drug safety-related, regulatory/policy-related, or therapeutics-related topic discussions)
- Participate in training and meetings as assigned by the preceptor.
- Student Assessment and Grading: The preceptor will assess the student on performance and professionalism at the midpoint and end of the rotation.