Safety and Medical Quality Lead - Observational Research
Safety and Medical Quality Lead - Observational Research
Posted on :
03-02-2025
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Job Description
Job Title: Safety and Medical Quality Lead 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 LEADOBSERVATIONAL RESEARCH
LIVE
What You Will Do
Let’s do this. Let’s change the world. This role will lead Safety and Medical Quality processes with a focus on Observational research activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan the preparation and execution of audits the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections.
The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs and escalation to compliance and quality oversight bodies and participate in quality investigations management and remediation.
Primary responsibilities:
What We Expect Of You
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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
Let’s do this. Let’s change the world. This role will lead Safety and Medical Quality processes with a focus on Observational research activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan the preparation and execution of audits the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections.
The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs and escalation to compliance and quality oversight bodies and participate in quality investigations management and remediation.
Primary responsibilities:
- Plan conduct and report on riskbased GPvP audits
- Assess and manage risks including providing input into the development of the annual GPvP audit plan.
- Provide Quality input for the risk assessment (CTRACT) process relating to Observational research studies
- Act as the Quality Lead contact for vendor evaluation activities relating to observational research studies
- 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
- Prepare analyze and communicate compliance metrics (e.g. audit and inspection data) and other significant compliance information.
- Maintain knowledge of current regulatory and compliance practices/issues assess changes in regulations and the external environment and advise customers.
- Support inspections and external audits including preparing conducting and closing out response reviews.
- Provide support for audit planning meetings debriefs audit plan outlines and response reviews
- Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA).
- Develop longterm remediation's and process improvements through Root Cause Analysis (RCA).
- Organizational Leadership
- Ability to Network
- Analytical Skills
- Decision Making
- Risk assessment and management
- Verbal and Written Communication
- Teamwork
- Time Management
- Interpersonal Skills
- Problem Identification and Resolution
- Ability to identify and implement process improvements
- Conflict Management
- This role requires up to 20% travel
What We Expect Of You
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
- 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)
- Good working knowledge of global regulatory requirements for GPvP/ GCP and/or observational research
- Experience in training and mentoring GPvP auditors
- Experience with hosting partner audits/ regulatory inspections
- Experience and knowledge of requirements for computer systems audits
- Proven experience of working effectively in diverse teams
- 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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