- Parexel (Raleigh, NC)
- …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
- Black & Veatch (Raleigh, NC)
- …programs . Ability to write detailed reports **Certifications** First Aid, CPR, Drug testing certified, Safety and Health Program Administration, OSHA 10 ... ** Safety & Health Spec/Advisor - BESS - NC**...based in Asheville, NC. \#LI-CR1 **Key Responsibilities** + Performs drug and alcohol screens in accordance with company substance… more
- Parexel (Raleigh, NC)
- …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 (Raleigh, NC)
- …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
- United Therapeutics (Research Triangle Park, NC)
- …events (SAEs) that occur during studies as and when they are notified to Global Drug Safety to assist in identifying any emergent safety concerns that ... Medical Director - Medical Monitoring will ensure individual subject safety and the scientific integrity of studies during the...on study design, scheduled assessments, and protection of subject safety + Review and approve all versions of the… more
- Parexel (Raleigh, NC)
- …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
- EMCOR Group (Raleigh, NC)
- …+ **Assist in scheduling and documenting health exams post-accident drug testing** _Develop/revise/audit safety hazard assessment documentation completion ... relative humidity, cleanliness, and ventilation. **Job Summary** The Site Safety Manager serves as the specialist in safety... Safety Manager serves as the specialist in safety by developing and implementing best practices and procedures… more
- Parexel (Raleigh, NC)
- …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 (Raleigh, NC)
- …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 (Raleigh, NC)
- …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