Pharmacovigilance Officer

About the Role

Our client is seeking a meticulous Pharmacovigilance Officer to join their dedicated, remote-based safety surveillance team. In this critical role, you will be responsible for the ongoing monitoring and reporting of adverse events associated with their pharmaceutical products. You will play a key part in ensuring patient safety and regulatory compliance by meticulously collecting, evaluating, and reporting safety data from various sources, all managed within a fully remote operational framework. This is an ideal position for a detail-oriented professional passionate about drug safety and regulatory affairs, seeking to contribute significantly from a home-based setting.

Key Responsibilities

• Collect, assess, and report adverse event data in accordance with regulatory guidelines and company SOPs.
• Perform case processing and quality checks for incoming safety reports to ensure accuracy and completeness.
• Contribute to the preparation of aggregate safety reports, such as Periodic Safety Update Reports (PSURs).
• Liaise with healthcare professionals, regulatory authorities, and internal departments regarding safety information.
• Stay abreast of evolving global pharmacovigilance regulations and guidelines.

Requirements

• Degree in Pharmacy, Medicine, Nursing, or a related life science field.
• Proven experience in pharmacovigilance or drug safety monitoring.
• Strong understanding of global safety reporting regulations and requirements (e.g., FDA, EMA).
• Proficiency in pharmacovigilance databases and case processing software.
• Excellent analytical skills, attention to detail, and strong written and verbal communication abilities.

Benefits

• Competitive salary and bonus structure.
• Fully remote work arrangement with home office support.
• Comprehensive health, dental, and vision insurance plans.
• Generous annual leave and public holiday allowance.
• Continuous professional development opportunities in drug safety and regulatory affairs.