Clinical Medical Services Specialist III

Pay Range 29-39/hr (depending on experience) Responsibilities Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (post marketing) is performed in a compliant and timely manner to comply with global regulations including: Seriousness assessment Labeling Causality Initial and Follow-up Other responsibilities include: Ensuring 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 core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One Decide Smart and Sure. Participating in audits and inspections as needed. Developing knowledge and expertise to mentor MSA’s in vendor management. Supporting development of materials and delivering training in conjunction with vendors, including train‑the‑trainer, special topics, refresher, and internal trainings as needed. Other duties may be assigned as needed. Experience and Skills Nursing experience and preferably experience with critical care, ICU, cardiac, or ER. Pharmacovigilance experience preferred. Minimum: Bachelor’s degree in Life Science. RN, BSN, BS, BS Pharm, PharmD or advanced degree. 2-4 years clinical experience or 2-3 years clinical experience and 1 year pharmacovigilance experience. Ability to lead project work and achieve results‑driven process management. Ability to work collaboratively in a team environment. Understanding of the changing regulatory environment and its impact on case management processes. Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA). Competent in case processing processes, procedures, conventions. Provides medical support with emphasis on intake of medical product experiences and processing standard communication requests; acts as a liaison with Quality Assurance for product quality problems involving adverse events; works with Customer Service to provide standard information and product replacement as needed; provides assistance to the medical and lay community with standard information from the package insert or standard letter database for labeled and specific off‑label indications. #J-18808-Ljbffr