Medical Writing Word Processing Coordinator II

Pay range: 33-43/hr
*depending on experience

Job Description:
Collect, assess, and process adverse event information (both clinical and post-marketing) in a compliant and timely manner to adhere to global regulations. This includes:
Seriousness assessment
Labeling
Causality determination
Initial and follow-up evaluations
Ensure adherence to company standards for quality, compliance, and productivity.
Stay updated on the knowledge and skills required for effective case processing.
This role is crucial for maintaining compliance with global regulatory standards and ensuring the highest quality of adverse event management.

Experience/Skills:
Minimum qualification: Bachelor's degree with a related health sciences background such as RN, BSN, BS, or BS Pharm. Candidates with previous pharmaceutical experience may also be considered even if they lack the appropriate degree.
Required experience: 2-4 years of clinical experience, or 2-3 years of clinical experience combined with 1-year of Pharmacovigilance experience.
Essential knowledge: Familiarity with industry regulations such as ICH, FDA, EMEA, and MHRA.
Competency: Proficiency in case processing processes, procedures, and conventions

Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.