Global Pharmacovigilance Data Specialist

ProductLife Group; Florida; Sur place; USD 55 000 - 75 000; Plein temps

Résumé du poste

ProductLife Group in Florida is seeking a dedicated pharmacovigilance professional to perform data entry of vigilance cases, draft initial communications, and submit cases to authorities. You will support ICSSRS monitoring, XEVMPD updates, and contribute to safety documentation.

The role requires a science background, at least 2 years in pharmacovigilance, and strong knowledge of GVP, GCP, FDA requirements, with excellent English communication and ability to meet deadlines.

Qualifications

• Bachelor’s degree in science/industrial biology/chemistry engineering.
• Min 2 years’ pharmacovigilance for service providers performing data entry and QC of cases.
• Experience meeting deadlines and client communications.
• Knowledge of EU PV regulations and regulatory drug safety requirements.
• Deep knowledge of pharmacovigilance principles, adverse event reporting and causality assessment.

Responsabilités

• Data entry of vigilance cases in relevant databases.
• Prepare initial email communications and requests for clarification.
• Submit cases to competent authorities.
• Draft reports from database queries.
• Monitor and download ICSSRS in national databases (EudraVigilance, MHRA portal).
• Recordings/updates on XEVMPD.
• Draft/update technical agreements / safety management plan / client template.
• Draft/update SOPs/WPDs/trainings or other documents related to PV activity.
• Participate in the implementation/maintenance/improvement of processes.

Connaissances

Database experience

Process oriented

Documentation

Computer skills

Team player

Medical terminology

Organized

Flexible

English communication

Formation

Bachelor’s degree in science/ Industrial Biology/Chemistry Engineer

Description du poste

ProductLife Group in Florida is seeking a dedicated pharmacovigilance professional to perform data entry of vigilance cases, draft initial communications, and submit cases to authorities. You will support ICSSRS monitoring, XEVMPD updates, and contribute to safety documentation.

The role requires a science background, at least 2 years in pharmacovigilance, and strong knowledge of GVP, GCP, FDA requirements, with excellent English communication and ability to meet deadlines.