Global Safety Senior Manager, Hematology Oncology - Remote

Career Category

Job Description

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.
 

Global Safety Senior Manager, Hematology Oncology
 

What you will do

Let’s do this. Let’s change the world. In this vital role you will support safety assessment activities for medical and scientific operations. This person will also provide scientific and compliance expertise to the Global Patient Safety (GPS) organization.

• Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.

• Perform data analysis to evaluate safety signals and write up analysis results.

• Author safety assessment reports as well as other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).

• Prepare and present the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies.

• Author and review portions of periodic aggregate safety reports (e.g. PBRERs, DSURs).

• Support clinical trial-related activities: provide support and oversight to staff with regards to safety in clinical trials; review and provide input and support on clinical trial-related documents (e.g. study protocols, statistical analysis plans, safety-related data collection forms, and the design of tables, figures, and listings for clinical trial safety data); review of adverse events or serious adverse events from clinical trials; and participate in study team meetings.

• Assist the GSO in the development of risk management strategies and activities: provide contents for risk management plans (RMPs); develop or update strategy and content for regional RMPs; assist the GSO in coordinating risk minimization activities including tracking of activities; evaluate risk minimization activities; and prepare responses to regulatory inquiries related to RMPs under the guidance of the GSO.

• Support activities related to new drug applications and other regulatory filings: assist the GSO in developing a strategy for safety-related regulatory activities; and provide safety contents for filings.

• Document work in the safety information management system.

• Organize and act as a direct liaison for safety activities with affiliates and other internal Amgen partners.

• Undertake activities delegated by the Qualified Person for PV as detailed in the PV system master file and maintain a state of inspection readiness.

• Represent and be the point of contact for health authority inspections and internal process audits within the remit of the role.
   

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 leader with these qualifications.
 

Basic Qualifications:

Doctorate degree and 2 years of directly related experience

OR

Master’s degree and 4 years of directly related experience

OR

Bachelor’s degree and 6 years of directly related experience

OR

Associate’s degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience
 

Preferred Qualifications:

• RN, PharmD, or PA

• 6 years of experience in a biotech/pharmaceutical setting

• Previous management and/or mentoring experience

• Experience in signal detection, evaluation and management

• Experience in aggregate data analysis, interpretation and synthesis

• Experience in authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs

• Clinical and/or medical research experience

• Knowledge of ICH guidelines, safety systems (e.g. ARISg and Argus) and MedDRA
   

What you can expect of us