What are the responsibilities and job description for the Regulatory Expert position at Abbott?
At Abbott, we are seeking a highly skilled Regulatory Expert to join our team. In this role, you will serve as an internal subject matter expert on pharmacovigilance, demonstrating a high level of scientific or technical expertise and an in-depth understanding of drug safety related processes.
You will participate in and oversee compliance of adverse events received for AN products in a compliant and timely manner. Additionally, you will ensure that any reports associated with products registered as pharmaceuticals or with other regulatory requirements for reporting are handled, processed and submitted according to applicable regulations.
As a Regulatory Expert, you will maintain documentation and perform quality control checks. You will also review literature search results and handle processing and maintenance of safety related data found in literature.
Your responsibilities will include reviewing aggregate safety data for inclusion in periodic reports, signal reports, and other pharmacovigilance related documents. You will assist in development and monitoring of product safety profiles of products registered as pharmaceuticals.
A Bachelor's degree with a related health science background is required, with a Master's preferred. You should have pharmacovigilance experience, including identifying, evaluating, and resolving significant medical and safety related issues in compliance with current good pharmacovigilance practices and relevant worldwide regulations and guidelines.
We are looking for someone with computer proficiency (Windows, Word, Excel) and experience working with drug safety databases. The ideal candidate will be able to present solid medical and scientific data orally and in writing. 5 years of experience level is required.
