Remote Clinical PV Adverse Event Specialist (Contract)

K3-Innovations, Inc.; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

K3-Innovations, Inc. is seeking a Clinical Medical Services Specialist III to support clinical and post-marketing adverse event case processing for a leading biopharmaceutical organization.

This remote, 1-year contract role targets professionals with 2–4 years of clinical experience or 2–3 years plus 1 year in pharmacovigilance. Responsibilities include AE collection and assessment, seriousness and causality determinations, timely case processing, and maintaining regulatory compliance with ICH,

Qualifications

• Pharmaceutical industry experience with clinical case processing is a must-have.
• Degree in a health sciences field or nursing/pharmacy; relevant experience may substitute.
• 2–4 years of clinical experience or 2–3 years plus 1 year in pharmacovigilance.
• Familiarity with regulatory guidelines (ICH, FDA, EMEA, MHRA).
• Proficient in adverse event case processing procedures and data quality.

Responsibilities

• Collect, assess, and process adverse event information from trials and post-marketing activities.
• Conduct seriousness, labeling, and causality assessments.
• Perform initial and follow-up AE case evaluations.
• Ensure timely, compliant case processing per global regulatory requirements.
• Maintain high standards of quality, compliance, and productivity.
• Stay current with regulatory requirements and best practices.

Skills

Clinical case processing

Regulatory compliance

Pharmacovigilance

Data quality

Attention to detail

Clinical data assessment

Education

Bachelor’s degree in Nursing/Health Sciences/Pharmacy

Tools

Veeva

Job description

K3-Innovations, Inc. is seeking a Clinical Medical Services Specialist III to support clinical and post-marketing adverse event case processing for a leading biopharmaceutical organization.

This remote, 1-year contract role targets professionals with 2–4 years of clinical experience or 2–3 years plus 1 year in pharmacovigilance. Responsibilities include AE collection and assessment, seriousness and causality determinations, timely case processing, and maintaining regulatory compliance with ICH,