Janice Miller, M.D.
Janice Miller, M.D. is a board certified Family Practice physician with 10 years of patient
care experience. Her pharmaceutical expertise is in both drug safety and medical affairs. She has had interactions with the
FDA during inspections and through her work on the iPLEDGE program. She has consulted for large and small pharmaceutical
companies including both branded and generic products.
Dr. Miller had been responsible for overseeing and coordinating all internal aspects of pharmacovigilance, drug safety, and
medical affairs worldwide. These responsibilities included: writing and reviewing periodic safety reports for health authorities,
creating and implementing procedures for the department, providing medical evaluation and review of all serious adverse events
(clinical trials) and all serious and non serious adverse events for marketed products. Her medical affairs responsibilities included:
medical review of all promotional, marketing and sales material, overseeing call center operations, training internal and external
parties, and responding to health care providers, consumers, and other individuals requesting information. Additionally, she provided
support to other departments, including Regulatory, QA, Clinical, and Sales/Marketing related to drug safety and medical affairs. Dr.
Miller has experience in ARISg and the Argus safety databases. Her expertise of the Argus Safety Database includes participating in the
validation of the system.
In addition to her work in the pharmaceutical industry, Dr. Miller has developed an educational tool to help women keep track of their
breast exams. This is currently licensed by a large pharmaceutical company for their breast cancer patient program.
Dr. Miller is currently consulting in the industry:
- Drug safety and pharmacovigilance systems
- Medical affairs
- Standard operating procedures, policies, work practices - writing/review
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