New York City
3 months ago
My client is an international pharmaceutical company focused in the research and development of proprietary and off-patent drugs. Very well-established with around 200 of its own drugs sold on a global scale. Currently seeking a 'Manager, Drug Safety' to play a key role in managing adverse safety reports to the FDA. Reports to Senior Manager, Drug Safety.
- Responsible for receiving, evaluating and completing adverse event reports for all of the company's products
- Compile and submit regular periodic adverse safety reports and submit individual safety reports to the FDA
- Manage timelines to ensure all deadlines are met and reports are submitted on an annual and quarterly basis
- Communicate with vendors, patients, physicians, and the FDA to reconcile any issues in regards to adverse events and drug safety
- Develop and implement SOPs
- Review signal detection and trending reports as necessary
- Participate in FDA PV inspection
- Medical degree, registered Nurse, or PharmD with 5+ years of industry experience
- Knowledge of FDA and ICH regulations and guidelines
- Familiarity with MedRA, MedWatch, CML and Periodic Adverse Event reporting formats
- Expertise in periodic safety reports
- Demonstrated supervising abilities to manage safety report processing
- Enthusiastic, eager to learn, and adaptable to various responsibilities
If you are interested in joining an internationally-renowned pharmaceutical company where you can obtain global experience, this is the right opportunity for you. In this role, you will have an impact.
Please direct all questions to Madison Villarreal at email@example.com or call 347-305-7665.