Senior Pharmacovigilance Officer

About the Role

Our client is seeking a highly experienced Senior Pharmacovigilance Officer to contribute to their robust safety surveillance activities in Southampton . This critical role involves ensuring the continuous monitoring and assessment of drug safety profiles to protect public health. You will be responsible for managing adverse event data, performing signal detection, and contributing to risk management strategies. This is an exceptional opportunity for a seasoned professional to play a key part in maintaining drug safety and advancing patient well-being within a leading pharmaceutical company known for its commitment to ethical practices and scientific integrity.

Key Responsibilities

• Oversee the accurate and timely processing, assessment, and reporting of adverse event (AE) and adverse reaction (AR) reports.
• Conduct comprehensive safety data analysis, including signal detection and risk assessment activities.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., GVP modules).
• Collaborate with internal teams (Clinical, Regulatory, Medical Affairs) and external partners to manage safety data and communication.
• Provide expertise and guidance on pharmacovigilance matters to internal stakeholders and participate in regulatory inspections.

Requirements

• Bachelor's or Master's degree in a life science, pharmacy, medicine, or related healthcare discipline.
• Significant experience (5+ years) in pharmacovigilance , including hands-on experience with safety databases and regulatory reporting.
• Strong understanding of global pharmacovigilance regulations, GVP guidelines, and safety reporting requirements.
• Excellent analytical skills, attention to detail, and the ability to interpret complex safety data.
• Proficiency in English with strong written and verbal communication skills.

Benefits

• Highly competitive salary and a generous bonus incentive.
• Comprehensive private medical insurance and robust pension scheme.
• Flexible hybrid working arrangements to support work-life balance.
• Extensive opportunities for professional development, training, and career progression.
• A collaborative and supportive environment in Southampton , focused on patient safety and ethical drug development.