Remote Pharmacovigilence Associate

Summary

Luminary Group is seeking a detail-oriented Pharmacovigilance Associate fluent in Dutch to work remotely. The role involves monitoring the safety and efficacy of pharmaceutical products, collaborating with cross-functional teams, and maintaining knowledge of current regulatory requirements.

Requirements

• Fluency in Dutch and English, both written and spoken
• Minimum of 2 years of experience in Pharmacovigilance or a related field
• Strong knowledge of Pharmacovigilance practices and regulations
• Experience with case processing activities, including data entry, coding, and narrative writing
• Proficiency in using Pharmacovigilance databases and safety reporting systems
• Ability to work independently and prioritize tasks effectively
• Excellent attention to detail and accuracy in data entry and documentation
• Strong analytical and problem-solving skills
• Good interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams

Responsibilities

• Review and evaluate adverse event reports and other safety-related information for our client's products
• Perform case processing activities, including data entry, coding, narrative writing, and quality checks
• Conduct signal detection activities and contribute to the preparation of signal evaluation reports
• Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory authorities
• Participate in the development and implementation of Pharmacovigilance processes and procedures
• Assist in the training and mentoring of junior team members

Preferred Qualifications

• Experience with MedDRA coding and EudraVigilance is desirable
• Flexible to work in different time zones, if required