Pharmacovigilance Specialist

About the Role

Our client is actively seeking a detail-oriented Pharmacovigilance Specialist to join their safety monitoring team based in Manchester . This role is critical for ensuring the ongoing safety of our client's pharmaceutical products by meticulously collecting, assessing, and reporting adverse event data. You will play a key part in maintaining regulatory compliance and safeguarding public health, working closely with regulatory affairs, clinical development, and quality assurance departments. This position offers the chance to contribute to patient safety within a reputable pharmaceutical company committed to ethical practices and scientific rigor.

Key Responsibilities

• Collect, review, and process adverse event reports from various sources (e.g., clinical trials, spontaneous reports, literature).
• Perform initial case assessments, including causality evaluation and data quality checks.
• Ensure timely reporting of safety information to regulatory authorities and internal stakeholders in compliance with global regulations.
• Maintain accurate and up-to-date safety databases.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs) and risk management plans.
• Collaborate with clinical teams to ensure appropriate safety monitoring in ongoing studies.

Requirements

• Bachelor's degree in a life science, nursing, or pharmacy-related field.
• 2-4 years of experience in pharmacovigilance or drug safety.
• Solid understanding of global pharmacovigilance regulations and guidelines (e.g., GVP, FDA).
• Proficiency with pharmacovigilance database systems (e.g., Argus, ARISg).
• Strong analytical skills and meticulous attention to detail.
• Excellent written and verbal communication skills.

Benefits

• Competitive salary and potential for performance-based incentives.
• Comprehensive healthcare coverage, including medical, dental, and optical plans.
• Company-sponsored pension scheme.
• Generous annual leave and public holiday entitlement.
• Opportunities for specialized training and career advancement in drug safety.
• On-site amenities and a supportive team environment in Manchester .