Clinical Medical Services Specialist III

The Fountain Group; Ridgefield (CT); Hybrid; USD 58,000 - 62,000; Full time

Job summary

The Fountain Group is seeking a Clinical Medical Services Specialist III for a remote, 12-month assignment to support pharmacovigilance activities. The role involves collecting, reviewing, and processing adverse event reports in alignment with global regulatory requirements and company quality standards.

Applicants should have 2–4 years of clinical experience or 2–3 years with pharmacovigilance exposure, plus familiarity with ICH, FDA, EMA/EMEA, and MHRA guidelines.

Qualifications

• 2–4 years of clinical experience or 2–3 years plus pharmacovigilance experience.
• Familiarity with ICH, FDA, EMA/EMEA, MHRA guidelines.
• Knowledge of pharmacovigilance case processing and labeling requirements.

Responsibilities

• Collect, assess, and process adverse event information per global regulatory requirements.
• Perform seriousness assessments, causality determinations, and labeling evaluations.
• Conduct initial and follow-up case evaluations for timely processing.
• Ensure adherence to procedures, quality standards, and regulatory targets.
• Maintain up-to-date knowledge of pharmacovigilance regulations and best practices.
• Ensure high-quality documentation and compliant case management.

Skills

Clinical experience

Pharmacovigilance

Regulatory knowledge

Adverse event assessment

Documentation accuracy

Education

Bachelor's in Health Sciences

Job description

Title: Clinical Medical Services Specialist III

Location: Remote

Duration: 12 months (With Possible Extension/Hire)

Pay: $42 - $45/ hours

Job Summary

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.

Key Responsibilities

• 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.

Education Requirements

• 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.

Required Experience and Skills

• 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.