Pharmacovigilance Officer

About the Role

Our client is seeking a vigilant and experienced Pharmacovigilance Officer to join their safety monitoring team in Leeds . This hybrid role focuses on ensuring the safety of pharmaceutical products by collecting, assessing, and reporting adverse event data. You will play a vital role in maintaining patient safety and regulatory compliance by meticulously managing safety databases and contributing to risk management strategies. The ideal candidate possesses a strong understanding of pharmacovigilance principles and a commitment to upholding the highest standards of drug safety.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.
• Perform case narrative writing and ensure timely reporting to regulatory authorities.
• Maintain and update the company's safety database according to established procedures.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Liaise with internal departments and external stakeholders on safety-related matters.
• Participate in regulatory inspections and audits related to pharmacovigilance.

Requirements

• Degree in a life science, nursing, pharmacy, or related healthcare field.
• Significant experience (3+ years) in pharmacovigilance or drug safety.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., GVP).
• Proficiency in safety database systems and adverse event reporting tools.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent written and verbal communication abilities, with meticulous attention to detail.

Benefits

• Competitive salary and potential for performance bonuses.
• Hybrid working arrangements for a better work-life balance.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday allowance.
• Continuous professional development and training opportunities.