Pharmacovigilance Specialist

About the Role

Our client, a forward-thinking pharmaceutical company, is seeking a meticulous and proactive Pharmacovigilance Specialist to join their dedicated safety team. This fully remote position based in Cardiff will involve safeguarding public health by monitoring the safety profiles of medicinal products and reporting adverse events. You will be integral in ensuring regulatory compliance and contributing to the ongoing risk management of pharmaceutical products. This role is perfect for an individual who is passionate about patient safety, possesses strong analytical skills, and thrives in a collaborative, home-based work environment, allowing for excellent work-life balance.

Key Responsibilities

• Monitor, collect, and process adverse event reports for assigned pharmaceutical products.
• Ensure timely and accurate reporting of safety information to regulatory authorities worldwide.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Collaborate with internal departments (e.g., Clinical, Regulatory) and external partners to manage safety data.
• Maintain and update the company's safety database with all relevant information.
• Participate in regulatory inspections and audits related to pharmacovigilance activities.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Proven experience (3+ years) in pharmacovigilance or drug safety.
• In-depth knowledge of global regulatory requirements for pharmacovigilance (e.g., GVP, FDA regulations).
• Familiarity with safety databases and adverse event reporting systems.
• Strong analytical skills and meticulous attention to detail.
• Excellent written and verbal communication skills, with the ability to work independently.

Benefits

• Competitive salary commensurate with experience.
• Fully remote working arrangement, offering significant flexibility.
• Comprehensive health, dental, and vision insurance coverage.
• Generous annual leave allowance and company holidays.
• Opportunities for continuous professional development and training in a growing field.