Job Description
Career CategorySafetyJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Quality Assurance & Vendor Oversight LeadWhat you will doLet’s do this. Let’s change the world. In this vital role you will be responsible for oversight of all case intake and processing of safety information. Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Oversight of submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Provide audit & external inspection support.Supervision of 1-15 staff in Amgen India with responsibilities supporting case management and Pharmacovigilance Operation activities as required.Accountability for quality oversight of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases by all vendor case processing teamsSupervise vendors quality ISCR metrics management to ensure all worldwide regulatory authority requirements are metProvide vendors with resources and training to perform their roleAnalysis and communication of case Quality Control resultsResponsible for implementation of measures for case related quality issues from vendor(s)Customer concern of issues around quality and key performance indicators to PV Operations leadership as applicableLead vendor governance including annual updates to the applicable relationship/business plansProviding audit/inspection support for case management related activities, including liaising with vendors to provide support as applicableUndertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readinessMay assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicableOther duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisorKey Activities:Handling direct reports on a day-to-day basis and raising topics as needed to GPS senior leadership.Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processesOversee day-to-day local and vendor operations as outlined in the standard operating procedures and contractual agreementsIndependently handle vendor relationshipResponsible for the growth and development of direct reports.Liaison with affiliates as needed regarding case management issues regarding product safety issuesOversee/handle correspondence associated with AE reports involving possible litigationEnsure monthly review of performance metrics (e.g. quality, volumes, turnaround times) as outlined in contractual agreementsProvide subject matter expertise in the interpretation of regulations as it relates to case processingParticipate/support in audits/inspections and responses for case related findingsBuild and maintain good functional and cross functional relationships globallyWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek should possess these qualifications.Basic Qualifications:Doctorate degree and 2 years of directly related experience ORMaster’s degree and 8 to 10 years of directly related experience ORBachelor’s degree and 10 to 14 years of directly related experience ORDiploma and 14 to 18 years of directly related experience4 years of managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesKnowledge of global regulatory requirements for PharmacovigilanceExtensive people management experienceExpertise in all aspects of case managementExperience in handling vendor relationshipsMicrosoft Suite: Word, Excel, PowerPoint, Project, OutlookWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..
