Pharmacovigilence Associate - Dutch Speaking, Remote

View full description

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

Responsibilities:

• Review and evaluate adverse event reports and safety-related information.
• Perform case processing activities, including data entry, coding, and narrative writing.
• Conduct signal detection activities and prepare signal evaluation reports.
• Collaborate with cross-functional teams for timely and accurate reporting of adverse events.
• Develop and implement Pharmacovigilance processes and procedures.
• Assist in training and mentoring junior team members.
• Maintain knowledge of current regulatory requirements related to Pharmacovigilance.
• Ensure compliance with company policies and procedures.
• Contribute to the continuous improvement of Pharmacovigilance activities.