Pharmacovigilance Scientist Manager Full-time

Pharmacovigilance Scientist Manager

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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 Team's 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

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.