At a Glance
- Tasks: Lead safety strategies for clinical development and post-marketing phases in General Medicine.
- Company: Join Regeneron, a leader in innovative biopharmaceuticals with a collaborative culture.
- Benefits: Comprehensive health benefits, fitness centres, equity awards, and generous paid time off.
- Other info: Inclusive workplace with excellent career growth and on-site collaboration.
- Why this job: Make a real impact on patient safety and contribute to groundbreaking medical advancements.
- Qualifications: Master's, PhD, or PharmD with 7+ years in risk management within pharma or biotech.
The predicted salary is between 70000 - 90000 € per year.
The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. This includes safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.
A typical day might include:
- Complete signal detection activities in line with approved safety surveillance plan
- Perform signal evaluation for any identified signals and author the safety evaluation reports
- Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
- Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
- Participate in other risk management activities as appropriate for assigned compounds
- Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
- Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents
This role might be for you if you can/have the:
- Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
- Ability to work with a safety system database for purposes of medical case review and simple queries
- Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritise
- Ability to effectively communicate (verbal and written) safety findings
To be considered for this opportunity, you must have the following:
- Minimum a Master's, PhD, or PharmD
- 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Senior Manager, Global Patient Safety - General Medicine in Uxbridge employer: Regeneron
Regeneron is an exceptional employer that fosters a collaborative and inclusive work culture, providing comprehensive benefits tailored to support employee well-being and growth. With a strong emphasis on professional development and opportunities for advancement, employees in the Senior Manager, Global Patient Safety role can expect to thrive in a dynamic environment that values innovation and teamwork. Located in a vibrant area, Regeneron offers unique advantages such as access to cutting-edge resources and a commitment to making a meaningful impact in the field of medicine.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Global Patient Safety - General Medicine in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews! Research the company, understand their values, and be ready to discuss how your experience aligns with their needs. We want you to shine, so practice common interview questions and have your own ready to go!
✨Tip Number 3
Showcase your expertise! Bring along examples of your work or case studies that highlight your skills in safety data analysis and risk management. We love seeing how you’ve made an impact in previous roles!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always on the lookout for passionate candidates who are ready to make a difference in global patient safety.
We think you need these skills to ace Senior Manager, Global Patient Safety - General Medicine in Uxbridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Senior Manager role. Highlight your relevant experience in global patient safety and risk management, and don’t forget to mention any specific projects that align with the job description.
Showcase Your Skills:We want to see how you can apply FDA, EU, and ICH guidelines in your previous roles. Be specific about your experience with safety data aggregation and signal detection activities, as these are key aspects of the position.
Be Clear and Concise:When writing your application, keep it straightforward. Use clear language to communicate your achievements and experiences, especially when discussing your ability to effectively communicate safety findings.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensure you’re considered for this exciting opportunity at Regeneron.
How to prepare for a job interview at Regeneron
✨Know Your Safety Guidelines
Make sure you brush up on the relevant FDA, EU, and ICH guidelines related to pharmacovigilance. Being able to discuss these regulations confidently will show that you’re not just familiar with the theory but can apply it practically in your role.
✨Prepare for Signal Detection Discussions
Since signal detection is a key part of the role, be ready to talk about your experience with safety data aggregation and analysis. Think of specific examples where you’ve successfully identified and evaluated safety signals, and be prepared to explain your thought process.
✨Practice Your Presentation Skills
You’ll likely need to present findings at meetings, so practice delivering clear and concise presentations. Use real-life scenarios from your past work to illustrate your points, and make sure you can explain complex safety concepts in an easy-to-understand way.
✨Show Your Team Spirit
This role involves working with cross-functional teams, so highlight your collaborative experiences. Be ready to share examples of how you’ve worked effectively with others, especially in risk management activities or process improvement initiatives.
