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For Companies At a Glance
- Tasks: Join our Global Patient Safety team to enhance patient safety worldwide.
- Company: Regeneron, a leader in innovative pharmaceuticals with a collaborative culture.
- Benefits: Comprehensive benefits including health programs, fitness centres, and paid time off.
- Why this job: Make a real impact on global patient safety while working in a dynamic environment.
- Qualifications: Experience in pharmacovigilance and strong organisational skills are essential.
- Other info: Inclusive culture with excellent career growth opportunities.
The predicted salary is between 60000 - 80000 £ per year.
We are seeking a dedicated and dynamic Senior Manager to join our Global Patient Safety team, specifically supporting the Qualified Person(s) for Pharmacovigilance (QPPV) and their deputy. As a vital member of the QPPV Office, you’ll play a key role in ensuring the efficient functioning of global pharmacovigilance systems. This position offers an exciting opportunity to contribute to patient safety worldwide while being part of a collaborative and innovative environment.
A Typical Day
- Monitor and maintain the QPPV Office mailbox, ensuring timely responses and updates.
- Schedule QPPV Oversight meetings, coordinate attendance of subject matter experts, and prepare meeting minutes.
- Manage the QPPV Office SharePoint site, ensuring content is organized and accessible.
- Support the creation and maintenance of the Pharmacovigilance System Master File (PSMF) and its derivatives in compliance with EU and global legislation.
- Facilitate cross-functional communication between the QPPV Office and global business units.
- Participate in process improvement initiatives within the global safety department, enhancing operational efficiency.
- Collaborate on the development and maintenance of Standard Operating Procedures (SOPs), Working Instructions (WIs), and Business Process Tools.
- Assist with inspection readiness activities to ensure compliance with regulatory requirements.
This Role May Be For You
- You thrive in a collaborative, international matrix environment and excel at building partnerships internally and externally.
- You have a strong understanding of European pharmacovigilance legislation and global regulatory requirements.
- You possess exceptional organizational skills and can manage complex projects with precision.
- You are proficient in Microsoft Office and drug safety databases, with technical writing expertise.
- You bring direct pharmacovigilance experience in pharmaceuticals or biologics and have knowledge of EMA GvP modules.
- You are innovative, detail-oriented, and passionate about contributing to patient safety.
- You are skilled in problem-solving and can analyze diverse issues and data effectively.
To Be Considered
Candidates must have direct pharmacovigilance experience within the pharmaceutical industry or regulatory authority, with a focus on pharmaceuticals and/or biologics. Knowledge of European pharmacovigilance legislation, global regulatory requirements, and PV quality systems is essential. Proficiency in drug safety databases, Microsoft Office, and technical writing is required. Preferred qualifications include experience with EMA GvP modules and a proven ability to manage collaborative partnerships in an international matrix environment.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.
Senior Manager Global Patient Safety - QPPV Operations in Uxbridge employer: Regeneron
Contact Detail:
Regeneron Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Global Patient Safety - QPPV Operations in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in pharmacovigilance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their approach to patient safety and be ready to discuss how your experience aligns with their values and goals.
✨Tip Number 3
Show off your skills! Bring examples of your past work, especially any projects related to pharmacovigilance systems or compliance. This will help you stand out as a candidate who can hit the ground running.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of our team.
We think you need these skills to ace Senior Manager Global Patient Safety - QPPV Operations in Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your pharmacovigilance experience and skills. Use keywords from the job description to show that you understand what we're looking for.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're passionate about patient safety and how your background makes you a great fit for the Senior Manager role. Be genuine and let your personality shine through!
Showcase Your Organisational Skills: Since this role involves managing complex projects, be sure to provide examples of how you've successfully organised and coordinated similar tasks in the past. We love seeing those organisational skills in action!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Regeneron
✨Know Your Pharmacovigilance Inside Out
Make sure you brush up on your knowledge of European pharmacovigilance legislation and global regulatory requirements. Be prepared to discuss how your experience aligns with these regulations, as this will show your understanding of the role's core responsibilities.
✨Showcase Your Organisational Skills
Since the role involves managing complex projects and maintaining the QPPV Office SharePoint site, come prepared with examples of how you've successfully organised similar tasks in the past. Highlight your attention to detail and ability to keep things running smoothly.
✨Demonstrate Collaborative Spirit
This position thrives in a collaborative environment, so be ready to share experiences where you've built partnerships across teams. Discuss how you facilitated communication and worked with diverse groups to achieve common goals.
✨Prepare for Technical Questions
Expect questions related to drug safety databases and technical writing. Brush up on your proficiency in Microsoft Office and be ready to discuss any relevant tools or systems you've used. This will help you stand out as a candidate who is not only knowledgeable but also technically savvy.