Remote Pharmacovigilance Specialist III

The Fountain Group; Ridgefield (CT); Híbrido; USD 58.000 - 62.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Clinical experience

Pharmacovigilance

Regulatory knowledge

Adverse event assessment

Documentation accuracy

Educación

Bachelor's in Health Sciences

Descripción del empleo

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.