Pharmacovigilance Scientist Manager

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

PHARMACOVIGILANCE SCIENTIST MANAGER

What you will do

In this vital role the Global PV Scientist Manager works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.

• Contribute to the planning preparation writing and review of non-medical portions of aggregate reports

• Work with affiliates and other internal Amgen partners regarding deliverables

• Review of AE/SAEs from clinical trials as needed

• Review and provide input and support on study protocols statistical analysis plans and other clinical study-related documents

• Review standard design of tables figures and listings for safety data from clinical studies

• Participate in development of safety-related data collection forms for clinical studies

• Attend study team meetings as requested or needed

• Conduct signal detection evaluation and management

• Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO

• Prepare safety assessment reports and other safety documents and regulatory responses

• Search and review adverse event data literature and other safety-relevant data for the purpose of signal detection

• Participates in Safety Governance per Amgen processes

• Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body

• Assist GSOs and other Senior Scientists in the development of risk management strategy and activities

• Provide contents for risk management plans

• Update strategy and content for regional risk management plans

• Assist GSOs to coordinate risk minimization activities including tracking of activities as needed

• Evaluate risk minimization activity

• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO

• Support activities related to new drug applications and other regulatory filings

• Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities

• Provide safety contents for filings

• 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

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 a strong collaborator with these qualifications.

• Degree educated with directly relevant Global Patient Safety experience

• Clinical/medical research experience

• Experience in a biotech/pharmaceutical setting

• Strong technical competency

• Strong attention to detail and time management

• Strong written communication

• Strong planning and problem solving 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 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 regular office work either from our Cambridge or Uxbridge next generation workspace. Fully remote setting may be considered

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.