23 days old

Global Safety Medical Dir

Amgen
Thousand Oaks, CA 91360
  • Job Code
    125715057
Amgen

Job ID: R-104356
Location: Thousand Oaks, CA, US

Leads a team of dedicated medical reviewers for Amgen products to provide medical review of individual case safety assessment reports (ICSR) in Amgen Global Safety Database. Through this role, provides subject matter expertise and ensures consistent process and level of rigor applied across therapeutic areas (TA).
  • Lead a team of medical reviewers for ICSRs through the lifecycle of the product from all sources
  • Provide direct managerial responsibilities for Medical Review team; recruit, provide training and monitor adherence to Amgen's SOPs
  • Owner of medical review procedures; accountable for ensuring medical review processes are efficient and compliant with worldwide regulations and Amgen SOPs
  • Ensure collaboration of medical reviewers with GSO and PV Scientists to ensure proactive monitoring of product safety profile for Amgen products
  • Provides medical expertise and guidance to the case management team


Key Activities

  • Lead the medical review team to ensure consistent review of seriousness, listedness, causality, coding and narratives of individual case safety reports for all products.
  • Set strategic direction of the policies and procedures for medical review team
  • Establish clear polices for Medical Review of ICSR for case medical assessment and follow up.
  • Establish procedure to execute ICSR case escalation to GSO when there is a potential signal /safety issue
  • Establish policies and procedures for team to prepare, author and approve analysis of similar event reports
  • Ensure integrity of medical coding conventions, auto label tool, data collection methods, and systematic process improvements for AE processing
  • Develop and support training to Amgen employees on ICSR medical review
  • Facilitate development and analyze productivity and compliance metrics for AE medical review process
  • Ensure all SOPs are current and followed with regards to medical review practices
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Inspection Readiness Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Managerial responsibilities:
  • Hire, manage, mentor and develop GPS Medical review staff and ensure all staff have developmental plans, yearly goals and objectives
  • Provide expertise and guidance on teams for interdepartmental and cross-functional teams, including process improvement, standards development, and metrics


Knowledge and Skills

  • Strong knowledge of global regulatory requirements for pharmacovigilance
  • Clinical knowledge of therapeutic area patient populations, product class and Amgen products
  • Proficiency in technical safety systems including Safety Database and medical coding and auto-label tool
  • Knowledge of clinical trials and drug development
  • Critical thinking and problem solving skills
  • Strong written and oral communication skills

Education & Experience (Basic)
  • MD/DO or international equivalent plus 4 years relevant experience in PV; Education & Experience (Preferred)
  • MD/DO or international equivalent with demonstrated knowledge of Pharmacovigilance
  • 5 years or more of experience including directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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.



PI125715057
Posted: 2020-11-05 Expires: 2020-12-06

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Global Safety Medical Dir

Amgen
Thousand Oaks, CA 91360

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