Description: Experience Level = 5-7 Years These roles are 100% remote
Job Description: Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (clinical and post marketing) is performed in a compliant and timely manner to comply with global regulations including: o Seriousness assessment o Labeling o Causality o Initial and Follow-up · Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for case processing. · Supporting vendor case quality, case processing metrics and agility using the Client’s core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All · Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal Client’s trainings as needed.
Qualifications: Minimum: Bachelor’s degree in Life Science. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred. Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered. o 2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience. o Demonstrates ability to lead project work. Proven success in results-driven process management. o Demonstrates ability to work collaboratively in team environment. o Demonstrates understanding of the changing regulatory environment and impact to case management process o Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA). o Competent in case processing proceses, procedures, conventions.
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.
