Director, PV Operations US Local Safety Officer (US LSO)

Amgen is seeking a Director, Pharmacovigilance Operations US to join our team and work from Amgen's beautiful Thousand Oaks, CA campus.

To learn more about this position:

• Provide close guidance and oversight of Safety reporting in US commercial programs
• Manage US safety case report submission compliance to respective regulatory agencies, as appropriate.
• Manage US safety regulatory reporting and related activities
• Manage cross-functional training of US staff and vendors regarding the details of safety reporting requirements in the US

Key Activities

• Ensure clinical trial SAE data and post-market AE data are collected in line with regulatory requirements
• Ensure single case reports are processed in a timely manner to enable Amgen to remain compliant with expedited reporting regulations
• Develop local Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen clinical trials and 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 clinical trials and 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
• Ensure US local variations are addressed in adhering to global requirements for safety reporting; liaise with Healthcare Compliance, R&D Compliance, Quality, Law
• Facilitate actions between US commercial leads and Safety to implement corrective and preventative actions resulting from monitoring visits, audits and other activities
• Ensure US local variations are addressed in adhering to global requirements for safety reporting; liaise with Healthcare Compliance, R&D Compliance, Quality, Law
• Partner with CPQOT and GRDCA on monitoring visit and audit observations
• Support local Non-Amgen Sponsored Clinical Research-Investigatory Sponsored Studies
• Develop and support strong cross-functional relationships and communication
• Provide global leadership to manage, delegate and oversee functional staff and activities
• Develop and communicate plans/objectives to others
• Maintain knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods
• 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
• Manage capacity and resource management within the global group
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Maintain and implement functional curriculum
• Provide input to GRAAS contracting groups globally
• Develop, implement and oversee training within functional area, and as applicable for other functions and vendors
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
• Develop meaningful team goals in alignment with department goals
• Assist the leadership team to build an organization and processes that will support future department, company and industry challenges

Knowledge and Skills

• Able to effectively represent ideas both verbally and in writing.
• Sound knowledge of the global safety environment, regulations and guidance
• Project and/or Process Management experience & knowledge
• Sound understanding of safety data capture, representation and interpretation
• Sound 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
• Experienced in human resource management
• Able to organize, plan, and prioritize workload for the function

Basic Qualifications:

• Doctorate degree and 4 years of safety experience
  OR
• Master's degree and 8 years of safety experience
  OR
• Bachelor's degree and 10 years of Safety experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Able to effectively represent ideas both verbally and in writing.
• Sound knowledge of commercial programs and scientific communications
• Sound knowledge of the global safety environment, regulations and guidance
• Proactive involvement in the AE data collection design of all US commercial programs
• Project and/or Process Management experience & knowledge
• Sound understanding of safety data capture, representation and interpretation
• Sound 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
• Experienced in human resource management
• 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.

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.