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- Tasks: Lead pharmacovigilance operations and ensure compliance with safety reporting standards.
- Company: Join a leading pharmaceutical company dedicated to patient safety.
- Benefits: Attractive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic role with potential for career advancement and skill development.
- Why this job: Make a real difference in drug safety and work with industry experts.
- Qualifications: Experience in pharmacovigilance and project leadership required.
The predicted salary is between 60000 - 80000 £ per year.
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.
Responsibilities- 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.
- Perform 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.
- 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.
- Previous experience directly managing teams, projects, programs or directing the allocation of resources.
- 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.
Pharmacovigilance Operations Manager in Newtown employer: Amgen
Contact Detail:
Amgen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Operations Manager in Newtown
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by researching common questions specific to pharmacovigilance operations. We recommend practising your answers with a friend or in front of a mirror to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work or case studies that highlight your skills in safety reporting and vendor management. We want to see how you can add value to our team!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Pharmacovigilance Operations Manager in Newtown
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Pharmacovigilance Operations Manager role. Highlight your relevant experience in safety reporting and vendor management, and don’t forget to showcase your project leadership skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that align with the job description, especially around compliance and training.
Showcase Your Skills: Don’t just list your skills; demonstrate them! Use examples from your past work to show how you’ve successfully managed teams or projects, particularly in pharmacovigilance or related fields.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and get you on our radar quickly!
How to prepare for a job interview at Amgen
✨Know Your Regulations
Make sure you brush up on global regulatory requirements for pharmacovigilance. Being able to discuss FDA and EMA guidelines confidently will show that you’re not just familiar with the role but also understand the critical compliance aspects.
✨Showcase Your Leadership Skills
Prepare examples of your project leadership experience. Think about times when you managed teams or resources effectively, especially in high-pressure situations. This will demonstrate your capability to lead and support case management activities.
✨Vendor Management Insights
Be ready to discuss your experience with vendor oversight and compliance. Share specific instances where you ensured quality measures were met and how you handled any challenges. This will highlight your ability to manage relationships and maintain high standards.
✨Prepare for Case Scenarios
Anticipate questions related to individual case safety reports (ICSR) processing. Think through how you would handle case-related queries or issues, and be prepared to discuss your approach to training vendors and staff on case management conventions.