Clinical Medical Services Specialist

Job Summary

To support pharmacovigilance efforts, the Clinical Medical Services Specialist III will collect, review, assess, and process clinical and post-marketing adverse event reports in a remote capacity for a duration of 12 months, with the possibility of extension or hire.

Key Responsibilities

• Collect, assess, and process clinical and post-marketing adverse event information in accordance with global regulatory requirements
• Perform seriousness assessments, causality determinations, and labeling evaluations for adverse event cases
• Ensure adherence to company procedures, quality standards, regulatory requirements, and productivity targets

Required Qualifications

• Bachelor's degree in a related health sciences field such as Nursing, Biology, or Pharmacy
• 2-4 years of clinical experience or 2-3 years of clinical experience combined with at least 1 year of pharmacovigilance experience
• Familiarity with global regulatory guidelines and requirements, including ICH, FDA, EMA/EMEA, and MHRA
• Knowledge of pharmacovigilance case processing procedures and workflows
• Understanding of adverse event assessment, seriousness classification, causality determination, and labeling requirements