Global Safety Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

GLOBAL SAFETY MANAGER

LIVE

What you will do

In this vital role you will be responsible for ensuring adherence to Amgens regulatory commitment for will provide management of a subset of safety activities within the UK and Ireland affiliate working with both local and global colleagues and based on sound knowledge of pharmacovigilance regulations and company procedures.

• Pharmacovigilance Legislation: Maintain own current knowledge of and compliance with local safety regulations.

• Case management: Perform business critical core safety activities per legal deadlines including intake of AE reports follow up with HCPs for complete data ICSR report submission to regulators. Handling safety enquiries received to the departmental inbox from both internal and external stakeholders. Review metrics to monitor MHRA & HPRA submission compliance and share with Qualified Person for Pharmacovigilance (QPPV)/Regional Management.

• Periodic Reporting: Assist with submission of DSUR and PSUR safety reports to Regulators and Ethics Committees where applicable. Perform review of relevant PSUR safety signals for MHRA notification.

• Risk Management: Support for safety risk communications (e.g. Dear Investigator Letter Urgent Safety Measures Risk Minimisation Materials etc.) and Risk Management Plans in conjunction with Regulatory Affairs Clinical and Medical Departments. Maintain awareness of safety profiles of designated Amgen products and new risk information.

• Leadership:Provide management of a subset of safety activities whilst reporting to the Senior Global Safety Manager. Provide input into cross functional programs to reflect local requirements or operating environment. Support with process improvement initiatives and implementation of legislative as a safety subject matter expert with the affiliate.

• Deputise: Assist Senior Global Safety Manager / Country Safety Lead with escalation of issues to Regional Management / QPPV and support with issue for Senior Global Safety Manager when necessary.

Be part of our team

You will be joining the UK & Ireland Safety Team based in the local affiliate and collaborating with other affiliate functions and also with Global Patient Safety colleagues to meet business needs. Together with team members you will conduct business critical safety tasks provide support to audits and inspections and assist the Senior Global Safety Manager with activities and issue resolution where necessary. Within the team you will maintain awareness of current prescribing information safety profile and new risk information for designated Amgen products to support product safety activities.

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:

• Graduate with life science or healthcare degree and proven relevant industry experience within post market and clinical trial pharmacovigilance
• Use of MS Office products to a proficient standard Word Excel PowerPoint
• Deep knowledge of processes and regulations in pharmacovigilance
• Experience with Safety Databases
• Strong initiative and problem-solving skills
• Natural team player with the personal qualities to relate well to people at all levels
• Aptitude for analytical thinking with a methodical approach and unquestionable attention to detail
• Highly motivated quick to learn with ability to work effectively under own initiative and a strong drive for excellence

THRIVE

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 well-being.

• Vast opportunities to learn and move up and across our global organization
• 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

LOCATION: Ability to work flexibly from home with occasional office work from our Cambridge next generation workspace.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.

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.