Director Global Safety- Global Periodic Aggregate Safety Reports
Amgen
Summary
In this vital role you will be accountable for development of Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs) in compliance with global regulatory requirements and Amgen compliance policies and standards.
Job description
What you will do
In this vital role you will be accountable for development of Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs) in compliance with global regulatory requirements and Amgen compliance policies and standards.
The Global Safety Director is accountable for all aspects of PASRs and periodic reporting processes, schedules, outputs, and metrics throughout the product’s life cycle. You will lead a global team with members in US/EU and Amgen India.
Responsible for participating in cross-functional activities to ensure and promote compliance and consistency with PASR preparation for all Amgen products throughout the life cycle of the product.
Key Responsibilities:
- Provide global leadership for PASR team to ensure all regulatory requirements for PASRs are met in the production and submission of all reports.
- Accountable for the development and maintenance of the Global Periodic Reports Schedule, Standards and Procedures
- Accountable as liaison between external vendors, Global Patient Safety, and cross functional teams (Regulatory Science, Global Clinical Development, Global Biostatistical Sciences, TS&BA, Centre for Observational Research) in the creation of PASRs
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
- Be point of contact for Health Authority Inspection and Internal Process Audits within the remit of the role and responsibility.
- Manage Global staff in functional area
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
Doctorate degree and 4 years of Global Safety experience OR Master’s degree and 8 years of Global Safety experience OR Bachelor’s degree and 10 years of Global Safety experience
In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Requirements
- Doctorate degree and 4 years of Global Safety experience OR Master’s degree and 8 years of Global Safety experience OR Bachelor’s degree and 10 years of Global Safety experience
- At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Retirement and savings plan
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus
- Stock-based long-term incentives
- Paid time-off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.