Sr Manager Global Safety - South San Francisco or Thousand Oaks, CA: NB50272910

Amgen (NASDAQ:AMGN), 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. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.NOTE: Work location for this position can be either South San Francisco, CA or Thousand Oaks, CA.This is an opportunity for a Sr. Manager position in the Therapeutic Area Safety group within Amgen Global Safety. The Therapeutic Area Safety group provides continuous assessment, management and timely communication of the benefit/risk profile for all Amgen products.Role/Purpose:- To provide medical and safety input into the clinical scope, review criteria, analysis and interpretation of safety issues- To develop and execute the safety surveillance strategy for product candidates/products in clinical development programs/approved products- To support the GSO as the focal point for product safety information communication- To support the GSO in preparation of Risk Management plansKey responsibilities include:- Support Global Safety Officer (GSO) to define clinical scope of a safety concern including analytical strategy and interpretation of findings- Responsible for producing Product Safety Review Meetings (PSRM) presentations and content driven documents under the guidance of the GSO- Contribute content support to the development of strategy and creation of product risk management plans including maintenance and updates- Review materials for the quarterly product safety review- Support the GSO for the following activities:- Investigator Meetings, DMC Charters & Meetings, Responses to Regulatory Authorities, review and Approval of Safety Sections of CSR, Review and approval of CSS, Review and approval of 120-Day Updates- Provide safety input to global development plans & study concept documents- Support consistent safety communications for internal & external stakeholders- Support Amgen offices on safety issues and regulatory inquiries- Support compliance with global regulatory requirements- Perform staff education on product safety profiles & issues- Review Periodic SS Product Safety packages- Design or refine safety database search strategies- Develop and update safety sections of DCSI, CDS, and provide input for local labels- Develop strategies for responding to regulatory inquiries? Preparing ad hoc responses for safety clarification (ex. – IRB, Regulatory, Investigator)? Risk Management Plan content and review? Review and contribute to PSURs, PSRs, safety sections of CSRs, IBs, ISS? Review aggregate periodic reports? Collaboration with Epidemiology and Operations? Aid in CRF design and content review? Contribute to and review safety sections of protocols, ICFs, and study documents? Work with GSO and GSPM to ensure workload/resource planning? Collaborate and review SOPs and TMs as necessary- Bachelors (science preferred) plus a minimum of 4 years of biotech/pharmaceutical experience- Clinical experience, including training - Drug safety experience Preferred Qualifications:- Masters plus 3 - 5 years of biotech/pharmaceutical experience- Doctoral degree and 2+ years of biotech/pharmaceutical experience- Current registered medical license- Accredited fellowship or clinical experience in relevant therapeutic area specialty Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit: www.amgen.com Company: Amgen Inc Location: Thousand Oaks, CA 91319 Job Category: Biotech/R&D/Science Reference Code: 50272910