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- Tasks: Lead pharmacovigilance operations and ensure compliance with safety reporting.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Be part of a cohesive team focused on innovative approaches to success.
- Why this job: Make a real impact on patient safety and work with a dynamic team.
- Qualifications: Experience in project leadership and understanding of global regulatory requirements.
The predicted salary is between 60000 - 80000 £ per year.
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
What you will do
In this vital role your primary responsibility will be acting as US/EU local safety office and FDA/EMA point of contact for safety reporting. You will support the submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors. Supporting interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures. Ensuring vendor compliance with approved processes and training requirements. Audit & external inspection support.
- Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements
- Provide vendors with resources and training to perform their role
- Support the analysis and communication of case QC results
- Lead development and delivery of training materials for case management conventions
- Support resolution of case related specific queries
- Management of multiple business partner relationships for case management
- Support reviews of contract wording for case related data exchange
- Monitoring compliance regarding regulatory submissions and/or contractual wording for data exchange
- Assign tasks within Case Management to direct and indirect reports
- Support management of staff within Case Management
- Escalation of case processing issues
- Audit & external inspection support
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
- Day-to-day vendor management issues
- Interact with other local safety offices
- Ensure case processing timelines for AE intake, triage and submission are met
- Assess workload to assist in resource management
- Support on-boarding and on-going training of vendors
- Attend management meetings with vendors
- Support analysis of QC trends
- Support generating, communicating, and archiving of reports of QC findings
- Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
- Perform case review as required
- Lead development and delivery of convention-related training material
- Support training of local office staff
- Perform US case follow up activities
- Perform BP reconciliation as required by safety agreement
- Generate and distribute performance metrics (submission compliance, volumes, turnaround times)
- Support reviews of contract wording for case related data exchange
- Support regulatory inspection and support for vendor audits/inspections
- Oversee performance monitoring and relay metrics to vendors
- Support analysis of QC trends including actions/recommendations
- Generate, communicate, and archive report of QC findings
Be part of our team
You would be joining a dynamic, successful and cohesive team dedicated to achieving results, continuously exploring innovative approaches to success, all while ensuring the delivery of the best medicines to benefit patients.
What we expect of you
- Understanding of global regulatory requirements for pharmacovigilance
- Project leadership experience
- Competence in safety systems
- Experience in supporting inspections or internal audits
- Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
Education:
- Master’s degree and 3 years of directly related experience or
- Bachelor’s degree and 5 years of directly related experience or
- Associate’s degree and 10 years of directly related experience or
- High school diploma / GED and 12 years of directly related experience
Previous experience directly managing teams, projects, programs or directing the allocation of resources.
Pharmacovigilance Operations Manager employer: Amgen Inc. (IR)
Contact Detail:
Amgen Inc. (IR) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Operations Manager
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already at Amgen. A friendly chat can open doors and give you insider info that could make your application stand out.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Brush up on pharmacovigilance regulations and be ready to discuss how your experience aligns with the role. We want to see your passion for patient safety!
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've managed teams or projects in the past. We love candidates who can lead and inspire others in a dynamic environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining our mission to serve patients.
We think you need these skills to ace Pharmacovigilance Operations Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the Pharmacovigilance Operations Manager role. Highlight your project leadership experience and understanding of global regulatory requirements to catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you’re passionate about pharmacovigilance and how your background makes you the perfect fit for our team. Keep it engaging and relevant!
Showcase Your Team Management Skills: Since this role involves managing teams and projects, be sure to include examples of your leadership experience. We love to see how you've successfully directed resources and led teams in the past.
Apply Through Our Website: Don’t forget to apply through our careers page! It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our mission to serve patients.
How to prepare for a job interview at Amgen Inc. (IR)
✨Know Your Regulations
Make sure you brush up on global regulatory requirements for pharmacovigilance. Being able to discuss these confidently will show that you understand the landscape and can navigate it effectively.
✨Showcase Your Leadership Skills
Prepare examples of your project leadership experience. Think about times when you managed teams or resources, and be ready to explain how you achieved results while ensuring compliance with safety standards.
✨Familiarise Yourself with Safety Systems
Get comfortable with the safety systems relevant to the role. If you have experience with specific tools or software, be prepared to discuss how you've used them to enhance case management and reporting.
✨Prepare for Audits and Inspections
Since this role involves supporting inspections and audits, think of instances where you've been involved in these processes. Be ready to share how you ensured compliance and what you learned from those experiences.