Data Officer

This is a fully remote position, open to applicants in India.

📋 Description

• Input vigilance cases into appropriate databases

• Compose initial emails for follow-up inquiries and requests for clarification

• Submit cases to the relevant competent authorities

• Execute specific database queries to generate reports

• Monitor and retrieve ICSRs from national databases, including Eudravigilance and the MHRA portal

• Log and update information in XEVMPD

• Draft and revise technical agreements, safety management plans, and client templates

• Create and update SOPs, WPDs, training materials, and other documents pertinent to the activity

• Engage in the implementation, maintenance, and enhancement of processes

⛳️ Requirements

• Bachelor’s degree in Science, Industrial Biology, or Chemical Engineering

• At least 2 years of experience in pharmacovigilance, specifically with service providers handling data entry and QC of cases

• Prior experience working under deadlines

• Experience in client communications

• Familiarity with EU PV regulations

• Pharmaceutical background with a solid understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety

• Extensive knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment

• Preferred experience with databases

• Process-driven mindset

• Enjoyment in working with documentation

• Proficient computer skills

• Ability to work effectively within a team

• Knowledge of medical terminology

• Organized and adaptable

• Exceptional communication skills in English

🏝️ Benefits

• Opportunity to have a significant impact on global healthcare

• Career advancement opportunities

• Innovative and forward-thinking team environment

• Collaborative and purpose-driven work culture

• Global team setting