Pharmacovigilance Specialist

About the Role

Our client seeks a meticulous Pharmacovigilance Specialist to join their dedicated safety team in Cardiff . This crucial role involves safeguarding public health by ensuring the safe use of pharmaceutical products through diligent monitoring and reporting of adverse events. You will be responsible for collecting, assessing, and reporting suspected adverse drug reactions, playing a vital part in maintaining regulatory compliance and patient safety. This position requires a commitment to working on-site to foster close collaboration with the wider safety and regulatory affairs departments.

Key Responsibilities

• Collect, evaluate, and report adverse event data from various sources, ensuring timely and accurate submissions.
• Maintain the company's safety database, ensuring data integrity and compliance with global regulatory requirements.
• Conduct case processing, including case narrative writing, coding, and assessment of seriousness and expectedness.
• Support the preparation of periodic safety update reports (PSURs) and other regulatory submissions.
• Liaise with internal departments and external partners to gather further information on adverse events.
• Contribute to the development and implementation of pharmacovigilance processes and procedures.

Requirements

• Degree in Pharmacy, Medicine, Life Sciences, or a related healthcare discipline.
• Experience in pharmacovigilance , drug safety, or a related regulatory affairs role.
• Thorough understanding of global pharmacovigilance regulations (e.g., GVP, FDA guidelines).
• Proficiency in using safety databases and adverse event reporting systems.
• Strong analytical skills with meticulous attention to detail in data assessment and reporting.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex safety information.

Benefits

• Competitive salary package with regular performance reviews.
• Comprehensive health and well-being benefits.
• Opportunity to work with a leading pharmaceutical company on vital safety initiatives.
• Professional development and training in pharmacovigilance best practices.
• Be part of a team committed to ensuring patient safety and drug efficacy in Cardiff .