Global Safety Senior Manager, Rare Disease

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 Rare Disease

What you will do

Lets do this. Lets change the this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).

• Search and 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 and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
• Direct the planning preparation writing and review of safety portions of aggregate reports.
• Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body.
• Assist GSO in the development of risk management strategy and activities: Provide contents for risk management plans; Develop or update strategy and content for regional risk management plans;
• Assist GSOs to coordinate risk minimization activities including tracking of activities; 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 in developing a strategy for safety-related regulatory activities; Provide safety contents for filings.
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.
• Provide support for clinical trials to review and provide input to study-related documents (e.g. study protocols; statistical analysis plans; safety-related data collection forms; and design of tables figures and listings for safety data from clinical studies) and provide aggregate review of Adverse Events (AEs)/Serious Adverse Events (SAEs) from clinical trials.
• Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (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 leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of proven experience

OR

Masters degree and 4 years of proven experience

OR

Bachelors degree and 6 years of proven experience

OR

Associates degree and 10 years of proven experience

OR

High school diploma / GED and 12 years of proven experience

Preferred Qualifications:

• RN PharmD MPH or PA
• Extensive direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production
• Knowledge of processes and regulations for pharmacovigilance and risk management
• Clinical/medical research experience

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