Amgen is seeking a Global Safety Sr Medical Scientist to function as a Global Safety Physician (GSP) in Cambridge, MA to join Global Patient Safety (GPS) organization and serve as the medical expert of the team to support the Global Safety Officer (GSO) in the conduct of quality safety assessment and risk management processes and activities for an assigned set of products through the product\u2019s life cycle.The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.The GSP is responsible for the conduct of safety monitoring and accountable for executing all product related safety decisions and deliverables for assigned products as designated by GSO or Therapeutic Area Head (TAH). Global Safety Officer may delegate to the Global Safety Physician where medical input is needed.Key ActivitiesApplicable tasks may vary by product(s) assigned and are performed under the supervision of the GSO. The Global Safety Physician is responsible for the following:Directs the planning, preparation, writing and review of portions of aggregate reportsOrganize and direct liaison activities with affiliates and other internal Amgen partner regarding productsSupports and provides oversight with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documentsReview of AEs\/SAEs from clinical trialsReview standard design of tables, figures, and listings for safety data from clinical studiesParticipate in development of safety-related data collection forms for clinical studiesParticipate in study team meetings as requestedSignal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis resultsDocuments work as required in the safety information management systemAuthor Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSOSearch and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection for clinical trials and postmarketing safetyPrepare presentation of the Global Safety Team\u2019s recommendations on safety issues to the cross-functional decision-making bodyAssist GSO in the development of risk management strategy and activities: Provides contents for risk management plans; Develop or update strategy and content for regional risk management plans; Assist GSOs to oversee risk minimization activities including tracking of activities; Evaluate risk minimization activity; Prepare response to regulatory inquiries related to risk management plans under the guidance of GSOSupport activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities; Provide safety contents for filingsInspection ReadinessUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessBe representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility#LI-PostMD01Basic Qualifications MD or DO degree from an accredited medical schoolPreferred Qualifications Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) settingClinical\/medical research experienceProduct safety experience in the bio\/pharmaceutical industryPrevious management and or mentoring experienceExperience in leading teams and or projectsAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people\u2019s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world\u2019s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.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.
Website : http://www.amgen.com
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.