Medical Review Senior Associate Scientist

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.

Medical Review Senior Associate Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products.

Responsibilities:

• To support global individual case safety reports regulatory reporting compliance.

• To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)

• Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.

• To act as a point of contact for Case Management on medical content of ICSRs

• Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports

• Execute ICSR case escalation as appropriate

• Execute appropriate case follow up per SOPs

• Support medical coding conventions, and systematic process improvements for ICSR medical review

• Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.

• Support Quality Assurance of ICSR medical review (if applicable)

• Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable)

• Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor

Inspection Readiness:

• 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.

Basic Qualifications:

• MD/DO or international equivalent AND

• 1 year of related drug safety experience

• Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance

• Clinical knowledge of therapeutic area patient populations and drug class

• Proficiency in technical safety systems including Safety Database and medical coding

• Knowledge of safety data capture in Clinical Trials and Post Marketing setting

• Knowledge of clinical trials and drug development

• Knowledge of Amgen products and patient population (preferred)

Preferred Qualifications:

• MD/DO or international equivalent AND

• 3 years of relevant work

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, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.