Pharmacovigilance Officer

About the Role

Our client, a progressive pharmaceutical company, is seeking a dedicated Pharmacovigilance Officer to join their globally distributed safety surveillance team. This position, based in Belfast but operating fully remotely, is crucial for monitoring the safety profile of our client's marketed products and investigational drugs. You will be responsible for collecting, assessing, and reporting adverse event data, ensuring compliance with global safety regulations. This role offers a unique opportunity to work from home while making a significant contribution to patient safety on an international scale, within a company that champions remote work and professional autonomy.

Key Responsibilities

• Collect, process, and assess adverse event reports from various sources, including healthcare professionals, patients, and literature.
• Ensure timely and accurate reporting of safety data to regulatory authorities and other stakeholders in compliance with global regulations.
• Contribute to the preparation of aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs).
• Participate in signal detection and risk assessment activities to identify potential safety issues.
• Liaise with internal departments and external partners to gather necessary information for safety assessments.
• Maintain and update pharmacovigilance databases and ensure data quality and integrity.

Requirements

• Life Science degree or equivalent qualification (e.g., Nursing, Pharmacy).
• At least 2 years of experience in pharmacovigilance or drug safety.
• Strong understanding of global pharmacovigilance regulations and reporting requirements (e.g., GVP modules).
• Experience with safety databases (e.g., Argus, ARISg) is highly desirable.
• Excellent analytical skills and the ability to critically evaluate safety information.
• Proficiency in English, both written and spoken, with strong attention to detail.

Benefits

• Competitive remote-working salary and potential for annual bonus.
• Flexible working hours to accommodate a healthy work-life balance.
• Comprehensive home office setup support.
• Private health insurance and employee assistance program.
• Opportunities for advanced training and career progression in drug safety and risk management.