Clinical Medical Services Specialist III

Title:

Clinical Medical Services Specialist III

Location:

Remote

Duration: 12 months (With Possible Extension/Hire)

Pay: $42 - $45/ hours

The Pharmacovigilance Specialist will be responsible for collecting, reviewing, assessing, and processing clinical and post-marketing adverse event reports in a timely and compliant manner. The role involves evaluating adverse event cases for seriousness, labeling, and causality while ensuring compliance with global pharmacovigilance regulations and company quality standards.

• Collect, assess, and process clinical and post-marketing adverse event information in accordance with applicable global regulatory requirements.
• Perform seriousness assessments, causality determinations, and labeling evaluations for adverse event cases.
• Conduct initial and follow-up case evaluations to ensure accurate, complete, and timely case processing.
• Ensure adherence to company procedures, quality standards, regulatory requirements, and productivity targets.
• Maintain up-to-date knowledge of pharmacovigilance regulations, case processing guidelines, and industry best practices.
• Ensure high-quality documentation and compliance throughout the adverse event management process.

• Bachelor's degree in a related health sciences field, such as Nursing (RN/BSN), Biology, or Pharmacy (BS Pharm).
• Candidates with relevant pharmaceutical industry experience may also be considered without the preferred degree background.

• 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, workflows, and conventions.
• Understanding of adverse event assessment, seriousness classification, causality determination, and labeling requirements.
• Strong attention to detail, documentation accuracy, time management, and commitment to regulatory compliance.