Safety and Medical Quality Lead-Observational Research
Safety and Medical Quality Lead-Observational Research
Posted on :
06-02-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
06-02-2025
Job Description
Job Title: Safety and Medical Quality LeadObservational Research
Job Location: Uxbridge UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level:
At Amgen every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies reaching over 10 million patients worldwide. Leverage your highlevel expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious lifeinterrupting illnesses.
SAFETY AND MEDICAL QUALITY LEADOBSERVATIONAL RESEARCH
LIVE
What You Will Do
In this vital role the Quality Lead in the Safety & Medical Quality organization will identify and escalate compliance issues to oversight bodies participate in quality investigations management and remediation. This role focuses on Safety and Medical processes particularly Observational research activities. Responsibilities include leading the pharmacovigilance (GPvP) annual audit plan preparing and completing audits investigating and supervising Quality events and supporting partner audits and regulatory inspections.
Primary Responsibilities
The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organization. We are responsible for strengthening and enhancing the R&D Quality Management System providing Quality oversight on R&D processes and leading activities related to PV regulatory inspections and external audits of the Amgen PV system.
WIN
What We Expect Of You
We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:
What You Can Expect Of Us
As we work to develop treatments that take care of others so we work to care for our teammates’ professional and personal growth and wellbeing.
APPLY NOW
What we do is hard. It should be. We are working with each other against the challenges of today for the promise of tomorrow. Lead the way.
careers.amgen.com
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
SAFETY AND MEDICAL QUALITY LEADOBSERVATIONAL RESEARCH
LIVE
What You Will Do
In this vital role the Quality Lead in the Safety & Medical Quality organization will identify and escalate compliance issues to oversight bodies participate in quality investigations management and remediation. This role focuses on Safety and Medical processes particularly Observational research activities. Responsibilities include leading the pharmacovigilance (GPvP) annual audit plan preparing and completing audits investigating and supervising Quality events and supporting partner audits and regulatory inspections.
Primary Responsibilities
- Provide Quality input for processes relating to Observational research studies (e.g. the clinical trial risk assessment CTRACT)
- Participate as the Quality representative for evaluating qualifying and providing oversight of Pharmacovigilance vendors.
- Participate in due diligence activities for potential business development opportunities.
- Ensure proactive identification of issues relating to processes programs and external relationships escalate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations management and remediation
- Assess and manage risks including providing input into the development of the annual GPvP audit plan.
- Plan conduct and report on riskbased R&D audits
- Prepare and communicate compliance metrics (e.g. audit and inspection data)
- Stay updated on regulatory and compliance practices and advise stakeholders
- Triage and/or manage R&D/ Pharmacovigilance Publications compliance matters
- Support inspections and audit plannings
- Contribute to Continuous Improvement Initiatives
- Improve R&D processes by giving expertise in identifying robust Corrective and Preventive Action plans (CAPAs).
- Develop longterm remediations and process improvements through Root Cause Analysis (RCAs).
The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organization. We are responsible for strengthening and enhancing the R&D Quality Management System providing Quality oversight on R&D processes and leading activities related to PV regulatory inspections and external audits of the Amgen PV system.
WIN
What We Expect Of You
We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:
- Degree Educated
- Proven experience in R&D Operations and/or Quality experience in the Pharma/Biotech sector
- Demonstrated leadership expertise in developing teams coordinating projects or programs and advising resource allocation
- Proven track record with auditing preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP) and knowledge of global regulatory requirements
- Some knowledge of statistical programming used with observational research such as STATA or SAS
- Experience and knowledge of requirements for computer systems audits
- Excellent time management skills and the ability to handle competing priorities
- Exceptional oral and written communication and writing skills.
What You Can Expect Of Us
As we work to develop treatments that take care of others so we work to care for our teammates’ professional and personal growth and wellbeing.
- Clear and disciplined strategic vision for the future that leverages superiorquality products operational excellence and topshelftalent
- Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health finance and wealth work/life balance and career benefits
APPLY NOW
What we do is hard. It should be. We are working with each other against the challenges of today for the promise of tomorrow. Lead the way.
careers.amgen.com
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Employment Type
Full Time
Key Skills
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