Sr. Manager, US Local Safety Office

Amgen is seeking a Sr. Manager, PV Operations US Local Safety Office to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

The Sr. Manager, PV Operations US Local Safety Office reports to the Global Patient Safety & Pediatrics Team in PV Operations:

Develop local Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen commercial activities (e.g. patient support programs and market research) in compliance with regulatory requirements and Amgen policies and standards.

Ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across US commercial programs for all Amgen products.

Create local PV Operations safety data collection strategy across clinical trial and commercial programs in line with regulatory requirements and business needs

Duties Include:

• Support US Local Safety Office (LSO) as point-of-contact for commercial programs executive leadership and working teams for market research and patient support programs
• Monitor compliance and overall execution of Safety reporting requirements in US commercial programs
• Liaison between Commercial Programs Quality Oversight Team to execute Action Plans and remediation activities related to safety reporting in commercial programs
• Facilitate cross-functional training or US staff and commercial vendors regarding the details of safety reporting requirements in the US
• Create strategic data collection methods for, and ensure compliance in safety data collection for all Amgen Digital Health programs
• Manage the successful implementation of correction and preventative actions between commercial and Safety resulting from monitoring visits, audits and other activities
• Provide guidance and set direction for oversight of Safety reporting in US commercial programs, including Amgen Digital Health
• Ensure US local variations are addressed in adhering to global requirements for safety reporting; serve as liaison with Healthcare Compliance, R&D Compliance, Privacy, Quality and Law
• Facilitate actions between US commercial leads and Safety to successfully implement corrective and preventative actions resulting from monitoring visits, audits and other activities
• Facilitate training for US staff and commercial vendors regarding the details of US safety reporting requirements
• Responsible for developing and supporting strong cross-functional relationships and communication
• Partner with CPQOT and GRDCA on monitoring visit and audit observations
• Lead the implementation of new processes and methods within and across Global Patient Safety
• Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Provide input to GRAAS contracting groups globally

Basic Qualifications:

• Doctorate degree
• Master's degree and 2 years of Safety experience
• Bachelor's degree and 4 years of Safety experience
• Associate's degree and 10 years of Safety experience
• High school diploma / GED and 12 years of Safety experience

Preferred Qualifications:

• Able to effectively represent ideas both verbally and in writing
• Expert knowledge of the global safety environment, regulations and guidance
• Project and/or Process Management experience and knowledge
• Expert understanding of safety data capture, representation and interpretation
• Expert knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
• Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally
• Able to organize, plan, and prioritize workload for the function

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs 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.

Join Us

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.