Preceptor Training

            Worldwide Pharmacovigilance and Epidemiology Department

About Eli Lilly and Company

Lilly is a leading innovation-driven pharmaceutical corporation. We're developing best-in-class pharmaceutical products by applying the latest research from our own worldwide laboratories and from collaborations with well-known scientific organizations.  We're seeking answers for some of the world's most urgent medical needs. As our products save and improve lives, they also save overall health care costs: they are often less expensive than other forms of health care, such as surgery and hospitalization.  We employ more than 31,000 people worldwide and market our medicines in 179 countries. Lilly has major research and development facilities in 9 countries and conducts clinical trials in more than 30 countries.

Areas of Emphasis

The Worldwide Pharmacovigilance and Epidemiology Department is responsible for adverse event collecting, monitoring, evaluation and communication of information to ensure the safe use of Eli Lilly pharmaceutical products.  The department is responsible for the patient safety, prescriber confidence, product information, and regulatory compliance in regards to the safety profile of all Eli Lilly compounds and devices that deliver such compounds. The department provides an analysis of safety information to the product teams, the Global Operations Labeling Department (GOLD), regulatory scientists, and the legal department for discussion and decisions.   

Worldwide Pharmacovigilance and Epidemiology is composed of physicians, pharmacists, medical technologists, nurses, and other healthcare professionals that support the therapeutic areas focused upon by Eli Lilly and Company. Those areas are infectious disease, neuroscience, endocrine, oncology, cardiovascular and women’s health.  The department is responsible for handling safety issues for Eli Lilly products in clinical trials and for marketed products.

Specifically, the department writes safety reports on all Eli Lilly compounds for worldwide regulatory bodies including the FDA.  The Periodic Safety Update Report (PSUR) and the Periodic Adverse Drug Experience Report (PADER) are the primary safety reviews performed by Pharmacovigilance. In addition, the department responds to any inquiry from a regulatory body (regulatory inquiry) regarding safety concerns.  Proactive safety surveillance is performed by the department, and this assists in remaining current with the information in the safety database and keeping the product teams informed.

Pharmacy Externship Objectives

1. To provide the student with experience in the pharmaceutical industry.
2. To provide the student experience in the application of drug therapy and disease state knowledge in the analysis of safety data.
3. To strengthen the verbal and written communication skills of the student.
4. To provide the student with an exposure to the interaction between regulatory bodies and the pharmaceutical industry.
5. To provide the student an understanding of how safety data gets to a product label. 

Pharmacy Extern Activities

1. Complete a Journal Club, Special Project Presentation and a Formal Therapeutic Presentation.
2. Meet with pharmacists working in various areas throughout Eli Lilly and Company to gain an appreciation of the opportunities.
3. Develop an understanding of monitoring safety for pharmaceutical products by attending meetings between pharmacovigilance and the product teams.
4. Develop an awareness of the interaction between pharmacovigilance and epidemiology in reaching decisions surrounding the safety profile of a compound.
5. Complete a review(s) regarding questions on the safety profile of products (regulatory inquiries).
6. Develop a familiarity with various drug information resources that contain information regarding side effects such as Meyler’s Side Effects Of Drugs.

One-on-One Meetings

The following are the one-on-one meetings the pharmacy extern will complete based upon availability of the individuals:

Clinical Development Associate

Clinical Research Associate

Clinical Trial Operations

Consumer Technical Services

Disease State Specialist

Drug Information Residency Coordinator

Epidemiologist

Global Health Economics

GMI Management

Intelligence Center Personnel

Labeling

Medical Information (Global and United States)

Medical Writing

Pharmacovigilance physician

Regulatory Scientist

Visiting Scientist Program Director  

Evaluation

Evaluation of the pharmacy extern will occur at the mid-point and conclusion of the externship.  The evaluation will be done utilizing the Eli Lilly and Company Pharmacy Externship Evaluation tool.  The pharmacy extern will also be provided with continuous verbal feedback and coaching from the Pharmacovigilance preceptor and associates. Additionally, the pharmacy extern will be formally evaluated on their journal club presentation, special project presentation and formal therapeutic presentation.

Pharmacy Extern Workspace and Hours

A workspace/desk area with a computer will be provided to each student.  The pharmacy extern is expected to work 40 hours per week and may utilize flextime but must be available during the core hours (9am to 3pm).

Professional Library

Lilly Corporate Center has a well-equipped scientific library, which offers most journals within the therapeutic areas for which we have products.  If a journal is not available and is needed, the article may be obtained through the Indiana University Medical Center library or through inter-library loan.  Pharmacy externs are responsible for photocopying any material that is needed.  There is no charge associated with photocopying.  Journals may not be checked out of the library. Tertiary references are also available.  In addition to the library’s resources, access to the worldwide web and the virtual library (Intelligence Center) are available at the pharmacy extern’s workspace