Pharmacovigilance Associate

Luminary Group is currently seeking a highly motivated and detail-oriented Pharmacovigilance Associate who is fluent in Dutch to join our team. This position offers the opportunity to work 100% remotely. As a Pharmacovigilance Associate, you will play a crucial role in monitoring and ensuring the safety and efficacy of our client's pharmaceutical products.

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.
• Maintain knowledge of current regulatory requirements and guidelines related to Pharmacovigilance.
• Ensure compliance with company policies and standard operating procedures.
• Contribute to the continuous improvement of Pharmacovigilance activities and systems.

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