Pharmacovigilance Specialist - Drug Safety

About the Role

Our client is seeking a diligent and detail-oriented Pharmacovigilance Specialist to join their expanding drug safety team in Birmingham . This critical role involves monitoring and evaluating the safety profiles of pharmaceutical products throughout their lifecycle. You will play a key part in ensuring patient safety by identifying, assessing, and reporting adverse events, contributing to the overall risk management strategies of the company. This is an excellent opportunity to work within a supportive and scientifically driven environment, focusing on the crucial aspect of drug safety within the UK pharmaceutical sector, safeguarding public health.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources, ensuring timely and accurate data entry into safety databases.
• Assess the causality of reported adverse events and determine the need for regulatory reporting.
• Prepare aggregate safety reports, such as Periodic Safety Update Reports (PSURs) and Signal Detection Reports.
• Collaborate with regulatory affairs, medical affairs, and other internal departments to ensure compliance with safety reporting regulations.
• Participate in risk management planning and the development of risk management strategies for assigned products.
• Stay current with evolving global pharmacovigilance regulations and guidelines.

Requirements

• Bachelor's degree in pharmacy, nursing, life sciences, or a related healthcare field.
• Proven experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Strong understanding of global pharmacovigilance regulations and reporting requirements (e.g., GVP modules).
• Proficiency in using safety databases (e.g., Argus, ArisG) and adverse event coding dictionaries (e.g., MedDRA).
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication abilities.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive benefits package including health, dental, and life insurance.
• Company pension scheme and generous holiday entitlement.
• Opportunities for career advancement and specialized training in drug safety.
• A collaborative and ethical work environment focused on patient well-being.