Pharmacovigilance Specialist - European Markets

About the Role

Our client is looking for a skilled Pharmacovigilance Specialist to manage and maintain drug safety surveillance activities for their portfolio across European Markets , based in Cambridge . This role is essential for ensuring compliance with EU pharmacovigilance legislation, including GVP modules. You will be responsible for processing adverse event reports, performing signal detection, and contributing to aggregate safety reports and regulatory submissions. This is an excellent opportunity to contribute to patient safety and regulatory compliance within a dynamic pharmaceutical company.

Key Responsibilities

• Process and evaluate adverse event reports from various sources, ensuring timely and accurate data entry into safety databases.
• Perform initial signal detection and contribute to the assessment of potential safety signals.
• Assist in the preparation and submission of aggregate safety reports (e.g., PBRERs, DSURs) for European regulatory authorities.
• Ensure compliance with EU pharmacovigilance legislation, including Good Vigilance Practices (GVP).
• Respond to safety inquiries from regulatory authorities, healthcare professionals, and internal stakeholders.
• Support the development and implementation of risk management plans (RMPs).

Requirements

• Bachelor's degree in a life science, pharmacy, nursing, or related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance , with a focus on European regulatory requirements .
• Thorough understanding of EU GVP modules and pharmacovigilance processes.
• Experience with safety database systems (e.g., Argus, ARISg).
• Excellent attention to detail and organizational skills.
• Proficiency in English and at least one other European language is advantageous for operations in Cambridge and broader European markets.

Benefits

• Competitive salary and annual bonus.
• Comprehensive health, dental, and vision insurance.
• Pension scheme with company contributions.
• Opportunities for professional development and training in pharmacovigilance.
• Dynamic and collaborative working environment in the hub of innovation in Cambridge .