Pharmacovigilance Manager

About the Role

Our client is seeking an experienced and proactive Pharmacovigilance Manager to lead their safety surveillance activities for a fully remote position. This critical role involves overseeing the collection, assessment, and reporting of adverse event data to ensure patient safety and regulatory compliance across all therapeutic areas. You will manage a team of safety specialists, develop and implement robust pharmacovigilance systems, and act as the primary contact for safety-related regulatory inquiries. This is an exceptional opportunity to shape the safety strategy of a growing pharmaceutical company, working remotely with a high degree of autonomy and impact from anywhere in the UK.

Key Responsibilities

• Lead and manage the global pharmacovigilance operations, including adverse event case processing, signal detection, and risk assessment.
• Ensure compliance with global regulatory requirements for pharmacovigilance (e.g., FDA, EMA).
• Develop, implement, and maintain pharmacovigilance policies, procedures, and quality systems.
• Manage and mentor the pharmacovigilance team, fostering a culture of high performance and continuous improvement.
• Prepare and submit aggregate safety reports (e.g., PBRERs, DSURs) to regulatory authorities.
• Act as the company's representative in safety-related discussions with regulatory agencies and external partners.
• Oversee the risk management plan development and implementation for assigned products.

Requirements

• Advanced degree (MD, PharmD, PhD) in a health science-related field or equivalent experience.
• Minimum of 7 years of progressive experience in pharmacovigilance within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in global regulatory requirements for drug safety and GVP guidelines.
• Proven experience in managing a pharmacovigilance team and overseeing case processing and safety reporting.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent leadership, communication, and interpersonal skills, vital for remote team management.

Benefits

• Highly competitive salary and comprehensive benefits package.
• Significant bonus potential tied to individual and company performance.
• Fully remote work arrangement offering unparalleled flexibility.
• Generous allowance for home office setup and ongoing professional development.
• Opportunity to lead and build a critical function within a growing pharmaceutical company.