Data Officer

ProductLife Group; Florida; Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Database experience

Process oriented

Documentation

Computer skills

Team player

Medical terminology

Organized

Flexible

English communication

Ausbildung

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

Jobbeschreibung

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

Job Description

• Data entry of vigilance cases in the relevant databases
• Preparation of initial email (in the context of follow up request), requests for clarification
• Submission of cases to the competent authorities
• Carrying out specific queries in the databases in order to draft reports
• Monitoring and downloading ICSSRS in the national databases (Eudravigilance, MHRA portal)
• Recordings/updates on XEVMPD
• Drafting/updating of technical agreements /safety management plan /client template
• Drafting/updating of SOPs/WPDs/Trainings others documents directly related to their activity
• Participation in the implementation/maintenance/improvement of processes

Education And Experience

• Bachelor’s degree in science/ Industrial Biology/Chemistry Engineer
• Min 2 years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases
• Previous experience working to deadlines.
• Client communications
• Knowledge of EU PV regulations
• Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
• Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment

Skills

• Database experience preferred
• Process oriented
• Enjoys working with documentation
• Good computer skills
• Works well within a team
• Knowledge of medical terminology
• Organized
• Flexible
• Excellent communication skills in English