Safety and Medical Quality Manager - Observational Research
Safety and Medical Quality Manager - Observational Research
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Safety and Medical Quality Manager Observational Research
Job Location: Great Britain United Kingdom
Job Location Type: Remote
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 MANAGER OBSERVATIONAL RESEARCH
LIVE
What You Will Do
The Quality Manager in the Safety & Medical Quality organisation will identify compliance issues participate in audits quality investigations and remediation activities.
This role supports Safety and Medical processes with a focus on Observational research activities. Key responsibilities include supporting the pharmacovigilance (GPvP) annual audit plan preparing and completing audits investigating Quality events and assisting with partner audits and regulatory inspections.
Primary responsibilities:
The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organisation. We are in charge of 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 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 MANAGER OBSERVATIONAL RESEARCH
LIVE
What You Will Do
The Quality Manager in the Safety & Medical Quality organisation will identify compliance issues participate in audits quality investigations and remediation activities.
This role supports Safety and Medical processes with a focus on Observational research activities. Key responsibilities include supporting the pharmacovigilance (GPvP) annual audit plan preparing and completing audits investigating Quality events and assisting with partner audits and regulatory inspections.
Primary responsibilities:
- Plan conduct and report on riskbased R&D audits
- Support the completion of the audit plan for GPvP suppliers/vendors and processes
- Support investigations of deviations from GPvP and GCP processes including root cause analysis design development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs)
- Update records in the digital quality management system (DQMS) and track through to closure
- Collating and verifying objective evidence for inspection & audit driven CAPAs/EVs
- Data entry into the risk assessment tool (using risk assessment methodology)
- Support GxP audits from business partners GxP inspection readiness and inspection management activities
- Support R&D Quality governance in clinical development pharmacovigilance and/or observational research
- Assist with audit planning meetings debriefs audit plan outlines and response reviews
- Maintain knowledge of current regulatory and quality practices/issues
- Collate compliance metrics for presentations to key stakeholders
- Support vendor evaluations related to observational research studies and GPvP or GCP vendors
- Actively seek and implement innovative quality oversight methodologies to improve our processes (e.g. riskmethods using AI and Natural Language Processing and data analytics)
The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organisation. We are in charge of 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 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 the Pharma/Biotech sector
- Experience as an auditor preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP)
- Solid understanding of global regulatory requirements for GPvP/GCP/ observational research
- Experience in supporting GPvP/GCP audits or inspections
- Outstanding oral and written communication skills.
- Some knowledge of statistical programming tools such as STATA or SAS would be a plus
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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