- Amgen is seeking a Product Safety Director for Combination Products to join our team and work from Amgen’s appealing Thousand Oaks, CA campus!
- Amgen is a science-based biotechnology pioneer. Our innovative human therapeutics have changed the practice of A, helping millions of people in the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve new patients.
- Provides scientific input in the development and maintenance of digital heath technology assets
- Provides technical oversight to CPS staff in the authoring of combination product risk/benefit analyses
- Assists CPS staff in the assessment and management of combination product safety issues
- Scientific writing
- Ensures CPS staff report-ability assessment activities take place for device complaints/malfunctions
- Assists CPS staff input to combination product risk management documents (hazard analysis, user risk assessments, etc.) for clinical and commercial products
- Performs other duties related to the position as vital as defined in Standard Operating Procedures or as requested by his/her supervisor
- Ability to assume multi functional role in core Departmental activities
- Performs management activities for direct reports including mentoring, career development, training, etc.
- Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products
- Solid understanding of global regulatory requirements, standards, and guidance’s for pharmacovigilance/risk management in relation to combination products and standalone devices
- Understanding of device risk management methodology, tools, and terminology, including human factors engineering methodology
- Strong understanding of clinical and commercial drug/biologic pharmacovigilance/risk management processes
Qualification & Experience:
- 3+ years’ experience with pharmaceutical/biotechnology/device pharmacovigilance/risk management
- Master’s degree and 8 years of Safety or Combination Product Safety or Scientific experience
- Bachelor’s degree and 10 years of Safety or Combination Product Safety or Scientific experience
- Doctorate degree and 4 years of Safety or Combination Product Safety or Scientific experience
Vacancy Type: Full Time
Job Functions: General Business
Job Location: Thousand Oaks, CA, US
Application Deadline: N/A