Pharmacovigilance Officer

About the Role

Our client is seeking a vigilant and experienced Pharmacovigilance Officer to join their safety surveillance team, operating in a fully remote capacity. This role is crucial for monitoring the safety of marketed pharmaceutical products and ensuring compliance with global pharmacovigilance regulations. You will be responsible for the collection, assessment, and reporting of adverse event data, contributing to the safe use of medicines. This is an excellent opportunity for a dedicated professional who can manage their workload effectively from home, possesses a keen eye for detail, and is committed to patient safety and regulatory adherence within the Leeds area and beyond.

Key Responsibilities

• Collect, assess, and document adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Conduct case processing, including data entry, query resolution, and medical assessment of reported events.
• Prepare and submit regulatory safety reports (e.g., ICSRs) to health authorities within strict deadlines.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Participate in signal detection activities and contribute to safety database management.
• Liaise with internal departments and external stakeholders on pharmacovigilance matters.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Hands-on experience with adverse event case processing and safety databases.
• Good understanding of global pharmacovigilance regulations (e.g., GVP modules, FDA regulations).
• Excellent attention to detail, analytical skills, and ability to work independently in a remote setting.
• Strong written and verbal communication skills, essential for remote collaboration.

Benefits

• Competitive salary and potential for performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Flexible working hours to support work-life balance in a remote role.
• Company-provided home office equipment and a technology allowance.
• Access to online training and professional development resources in pharmacovigilance.