Global Safety Senior Manager, Hematology Oncology - Remote

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.

Global Safety Senior Manager Hematology Oncology

What you will do

Lets do this. Lets change the 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 Teams 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

Masters degree and 4 years of directly related experience

OR

Bachelors degree and 6 years of directly related experience

OR

Associates 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

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts
• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models including remote and hybrid work arrangements where possible

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.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

Salary Range