Job details
Job type full-time
Full job description
Career category
Safety
Job description
How might you defy imagination?
If you feel like you’re part of something bigger, it’s because you areAt amgen, our shared mission—to serve patients—drives all that we doIt is key to our becoming one of the world’s leading biotechnology companiesWe are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwideIt’s time for a career you can be proud ofJoin us.
Combination product safety medical director
Live
What you will do
Group purpose
Provide science-based evaluation of product quality and combination products, stand-alone devices, diagnostics and digital health safety issues for amgen products
Assess of potential impact of quality findings on patient/user safety for all clinical and commercial products
Review of adverse event data to detect potential product quality issues for commercial products
Provide 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
Job summary
The combination product safety medical director is the safety expert for assigned combination product this includes:
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 clinical input for combination product scientists
Provision of expertise for combination product safety data collection/analysis/reporting
Provision of expertise for combination product risk management activities
Key activities
Combination product safety
Assesses and manages combination product safety issues
Creates input for combination product risk management documents (hazard analysis, user risk assessments, human factors, etc.) for clinical and commercial products
Creates reportability assessment activities take place for device complaints/malfunctions
Provides clinical input in the development and maintenance of digital health technology assets
Provides medical oversight to cps staff for the combination product risk/benefit analyses
Provides clinical input for medical evaluations
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 management activities for direct reports including mentoring, career development, training, etc.
Performs other duties related to the position as necessary as defined in standard operating procedures or as requested by his/her supervisor
Knowledge and skills
Key competencies
Processes and regulations for pharmacovigilance and risk management in addition to combination products and stand-alone devices.
Advanced understanding of interfaces across various pharmacovigilance and risk management processes
Drug/device development and lifecycle management
Safety data capture in clinical development and post-market settings
Safety database structure and conventions
Meddra and other dictionaries used in pharmacovigilance and device reporting
Methods of qualitative and quantitative safety data analysis
Product and disease state knowledge
General medicine, epidemiology, physiology, and pharmacology
Internal organizational and governance structure
Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
Pharmacovigilance skills
Signal detection and evaluation
Aggregate data analysis
Good clinical and scientific judgment
Application of medical concepts and terminology
Document writing and source document review
Data interpretation and synthesis
Basic skills in application of statistical and epidemiological methods to pharmacovigilance
Ability to convey complex, scientific data in an understandable way
Ability to analyze and interpret complex safety data
Advanced skills in application of statistical and epidemiological methods to pharmacovigilance
Other skills
Strategic thinking
Effective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environment
Big picture perspective and context analysis
People and team management
Conflict management
Organization, prioritization, and planning of work
Project management
Critical scientific assessment and problem solving
Oral presentation skills
Written communications and medical/scientific writing
Computer skills (e.g., ms office suite and safety systems)
Competencies
Knowledge
Serves as a technical authority within the organization
Develops advanced/leading-edge technologies and/or concepts that have global reach and applicability
Problem solving
Applies global thought leadership
Shapes long-term strategic direction and reputation of amgen
Provides authoritative advice to top management
Leads organizational invention at a global level
Autonomy
Models organizational standards for innovation
Directs projects of critical importance to amgen
Contribution
Serves as expert advisor to top management and is a sponsor for large-scale projects
Ensures products and services are aligned with current and future needs and expectations including the following:
Business needs
Medical field
Research community
Creates solutions that enhance amgen’s intellectual property
Win
What we expect of you
Education & experience (basic)
Md or do degree from an accredited medical school
Completion of an accredited medical or surgical residency
5 years’ experience in drug safety
Significant (3 years+) experience with combination product safety
Education & experience (preferred)
Md, do, or equivalent degree from an accredited medical school
4 years of directly related experience or md of a foreign medical school
And
Product safety in the bio/pharmaceutical industry or regulatory agency
Previous management and/or mentoring experience
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous total rewards plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, amgen is the first to imagine, and the last to doubtJoin us.
Careers.amgen.com
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