Pharmacovigilance Specialist

About the Role

Our client is seeking a dedicated and meticulous Pharmacovigilance Specialist to join their safety monitoring team in Milton Keynes . This essential role involves the continuous monitoring of drug safety, including the collection, assessment, and reporting of adverse events associated with pharmaceutical products. You will work within a critical regulatory function, ensuring patient safety and compliance with global safety regulations. The ideal candidate will possess a strong understanding of pharmacovigilance principles and a keen eye for detail, contributing to the safety profile of our client's medicines in a dedicated office-based environment.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.
• Ensure timely and accurate reporting of safety information to regulatory authorities worldwide.
• Maintain and update the pharmacovigilance database with accurate case information.
• Participate in the preparation of periodic safety update reports (PSURs) and other regulatory submissions.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs) and external partners on safety-related matters.
• Contribute to the development and implementation of pharmacovigilance processes and procedures.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related healthcare field.
• Proven experience (minimum 3 years) in pharmacovigilance or drug safety.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., GVP, FDA regulations).
• Proficiency in using pharmacovigilance databases and safety reporting software.
• Strong analytical and critical thinking skills for case assessment.
• Excellent written and verbal communication skills, with meticulous attention to detail.

Benefits

• Competitive annual salary.
• Generous holiday allowance and company pension scheme.
• Private medical insurance and access to wellness programs.
• On-site parking and excellent transport links.
• Professional development and training opportunities within the pharmacovigilance field.