Clinical Medical Services Specialist III_35643

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

NOW HIRING: Clinical Medical Services Specialist III

Requisition #35643 | 100% Remote | 1-Year Contract

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

This is an excellent opportunity for a clinical or pharmacovigilance professional with pharmaceutical industry experience who is passionate about patient safety, medical data assessment, and regulatory compliance.

Contract Duration: 1 year

Education: Bachelor’s degree in Nursing, Health Sciences, Pharmacy, or a related field preferred

Experience: 2–4 years of clinical experience, or 2–3 years of clinical experience combined with 1 year of pharmacovigilance experience

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

Required Qualifications

• Pharmaceutical industry experience with clinical case processing is a must-have.
• Bachelor’s degree in a related health sciences discipline, such as RN, BSN, BS, or BS Pharmacy. Candidates with relevant pharmaceutical experience may be considered without the specified degree.
• 2–4 years of clinical experience, or 2–3 years of clinical experience plus 1 year of pharmacovigilance experience.
• Familiarity with regulatory guidelines and requirements, including ICH, FDA, EMEA, and MHRA.
• Proficiency in adverse event case processing procedures, processes, and conventions.
• Strong attention to detail and commitment to regulatory compliance and data quality.
• Experience with Veeva is highly beneficial, but not required.