Combination Product Safety Physician

Devices, in vitro diagnostics and digital health are at the forefront of Amgen's product development strategy. Ensuring the safe use of these technologies is of the highest priority within Global Patient Safety and as a result, a Combination Product Safety (CPS) Team has been established to provide safety expertise across the Amgen portfolio. The CPS physician will serve as the clinical expert for device, IVD and software product complaints for the Global Safety Therapeutic Areas. This physician is will also serve as a liaison to the operations / product complaint teams to ensure adverse event and product complaint information is well understood by the various teams.

Group Purpose

• To provide science-based evaluation of product quality and device, companion diagnostic and digital health safety issues for Amgen products
• Assessment of potential impact of quality findings on patient/user safety for all clinical and commercial products
• Act as a consultant for Therapeutic Area Safety (TAS) for assessment of adverse event data to detect potential product quality issues for commercial products
• Provision of expertise in combination product safety data collection / analysis / reporting in clinical trials, post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit / risk analyses

Key Responsibilities

The Combination Product Safety Physician leads the Combination Product Safety (CPS) Team in fulfilling its primary responsibilities:

• Assessment of potential impact of quality findings on patient/user safety for all clinical and commercial products in conjunction with members of the Global Safety Team
• Provide consultation to TAS for the review of adverse event data to detect potential product quality issues for commercial products
• Provision of expertise for device/combination product safety data collection/analysis/reporting
• Provision of expertise for device/combination product risk management activities

The Combination Product Safety Physician is expected to:

• Assess of potential impact of quality findings on patient/user safety for all clinical and commercial products in conjunction with members of the Global Safety Team
• Review of adverse event data to detect potential product quality issues for commercial products
• Provide expertise for combination product safety data collection/analysis/reporting
• Provide expertise for combination product risk management activities

Key Activities

Combination Product Safety

• Leads CPS staff in the assessment and management of device/combination product safety issues
• Leads CPS staff input to device/combination product risk management documents (hazard analysis, user risk assessments, etc.) for clinical and commercial products
• Provides clinical input in the development and maintenance of digital heath technology assets
• Provides clinical for the assessment of in-vitro diagnostics for development and marketed products

Inspection Readiness

• Undertakes activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Acts as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

General

• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Key Competencies

• Very strong knowledge of global regulatory requirements, standards, and guidances for pharmacovigilance/risk management in relation to combination products and standalone devices
• Very strong understanding of device risk management methodology, tools, and terminology, including human factors engineering methodology
• Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products
• Strong understanding of clinical and commercial drug/biologic pharmacovigilance/risk management processes

Skills

• Networking (cross functional)
• Relationship development and management
• Decision Making and prioritization
• Team work/collaboration
• Leadership and Management skills
• Regulatory interpretation
• Clinical case assessment
• Ability to assume multifunctional role in core Departmental activities
• Medical/scientific writing

Basic Requirements

MD or DO degree from an accredited medical school

Preferred Requirements

• Completion of an accredited medical or surgical residency
• Significant (3 years+) experience with pharmaceutical/biotechnology/device pharmacovigilance/risk management

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.