- Parexel (Tallahassee, FL)
- …labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness ... labels and Development Core Safety Information (DSCI) + Coordinate safety activities between Drug Safety Unit/team and internal and external partners +… more
- Parexel (Tallahassee, FL)
- …with **medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + **Exceptional ... looking to leverage their clinical expertise in the dynamic field of clinical drug development. As a medical expert and strategic partner, you'll play a pivotal… more
- Sumitomo Pharma (Tallahassee, FL)
- …partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills in signal detection, ... to manage the benefit/risk profile of assigned products and ensure patient safety . + Assist in signal detection activities including data assembly, signal… more
- Parexel (Tallahassee, FL)
- …study design/execution, preferred + Clinical practice experience + Good knowledge of the drug development process including drug safety , preferred + ... therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships… more
- Parexel (Tallahassee, FL)
- …level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to ... and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good… more
- Parexel (Tallahassee, FL)
- …level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to ... and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good… more
- Parexel (Tallahassee, FL)
- …of global labeling. Key Responsibilities: * Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership. * ... GLAMS. Competencies: * Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing. * Strong problem-solving skills… more
- Sumitomo Pharma (Tallahassee, FL)
- …authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- MyFlorida (Miami, FL)
- …Driver License (CDL), applicants must register with the Federal Motor Carrier Safety Administration's Drug and Alcohol (FMCSA) Clearinghouse, as required, for ... FDOT and be part of the team that works as one to improve safety , enhance mobility and inspire innovation in the Florida transportation system. To ensure honesty… more
- Oracle (Tallahassee, FL)
- …provider of integrated data collection and data management solutions for clinical trials and drug safety . As a member of the LSGIU development organization, you ... will contribute to a mission-critical platform that enables our customers to develop solutions that address worldwide healthcare problems in therapeutic areas such as vaccines and oncology with unmatched performance, scale, and reliability. A successful… more