Safety Advisor in City of Westminster

As a Safety Advisor at Boots, you'll play an important role in maintaining and continually improving vigilance processes. This is a broad role and you will be part of a specialist team combining scientific assessment, regulatory compliance, post-market surveillance, safety signal management and stakeholder collaboration to ensure product safety activities are delivered in line with applicable regulatory requirements and company standards.,

• Maintaining and continuous improve Boots' Pharmacovigilance, Medical Device Vigilance, and Cosmetovigilance processes.
• Liaise with customers, healthcare professionals, regulatory authorities, and internal stakeholders as part of the end to end post-market surveillance activities.
• Review, evaluate, and document Individual Case Safety Reports (ICSRs), medical device incidents and other product safety information.
• Perform analysis of safety data to support case processing, trend analysis and escalation of potential safety concerns
• Maintain allocated sections of PSMF, as well as authoring and maintaining procedures, signal management activities, including literature reviews and Periodic Safety Update Reports (PSURs), trend analysis and identification of emerging safety issues.
• Perform Cosmetovigilance activities, including the management of undesirable effects and serious undesirable effects associated with cosmetic products.
• Monitor and assess relevant regulatory intelligence and changes in vigilance legislation to support ongoing compliance.
• Manage a Product Enquiry service, providing accurate and scientifically robust responses to customers.
• Support audits, inspections, and compliance activities as required.
• Deliver technical training on safety and vigilance processes across the business.
• Build effective relationships with internal and external technical stakeholders., At Boots, your role as a Safety Advisor opens doors to various career pathways within our Quality & Technical Services team. With opportunities for professional development and continuous learning, you can advance your expertise in product safety and regulatory compliance. Your contributions will not only enhance your career but also play a vital role in ensuring the safety and well‑wellness of our customers.
• Experience in Pharmacovigilance, Product Safety, or a related scientific or regulatory discipline.
• Life Sciences degree or equivalent.
• Proven experience in reviewing and interpreting safety data within a regulated environment.
• Ability to apply critical thinking and scientific judgement when assessment product safety information.
• Strong attention to detail and focus on quality and regulatory compliance.
• Excellent written and verbal communication skills for diverse audiences.
• Strong organisational stills with the ability to manage multiple priorities and meet regulatory timelines.
• Good understanding of post-market surveillance principles and risk-based decision making.

It would be great if you also have

• Experience with drug safety databases or vigilance management systems.
• Knowledge of Good Pharmacovigilance Practice (GVP) and medical device vigilance requirements.
• Previous experience in Cosmetovigilance activities and cosmetic product safety programmes.
• Knowledge of UK and/or EU cosmetic product legislation.
• Experience authoring or contributing to aggregate safety reports, signal detection activities, trend analysis or regulatory submissions.
• Understanding of risk management principles and benefit‑risk assessment.

At Boots, we're proud to be an equal opportunity employer, creating a place where everyone feels welcome, supported and free to be themselves. We believe that when our people feel valued and included, they thrive, so we're committed to creating a brilliant Boots for our people so they can make a difference for our customers and colleagues every time.

• Boots Retirement Savings Plan
• Discretionary annual bonus
• Generous employee discounts
• Enhanced maternity/paternity/adoption leave pay and gift card for anyone expecting or adopting a child
• Flexible benefits scheme including option to buy additional holiday, discounted gym membership, life assurance, activity passes and much more.
• Access to free, 24/7 counselling and support through TELUS Health, our Employee Assistance Programme.

There's lots more in our benefits and discounts, MyBoosts - there to give you that little lift in your everyday. Find out more at http://boots.jobs/rewards. Exclusions may apply; eligible roles only. Please note that any salary estimates provided on third‑party sites are not endorsed by Boots and may not be accurate.

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