Amgen Jobshttp://www.amgen.jobs2012-05-27 00:55:23.899454USAThousand OaksAuto req 15192BR Job Posting Title Global Safety Sr Mgr Career Category Safety Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description To focus on device-related safety activities for one or more programs. To be subject matter expert in Amgen Global Safety for activities related to drug delivery device and combination product safety; establishment and execution of procedures and best practices related to device/combination product development and commercialization with respect to safety. To interface as device safety expert across multiple Amgen functional areas including Therapeutic Area Safety, Global Development, Safety Operations, Device Regulatory, Device Quality, and Drug Delivery Division. Job Summary: The Global Safety Scientist – Device, will conduct activities related to device safety by providing technical expertise and support to the Global Safety Officer (GSO) and Global Safety Team (GST) for product-associated drug delivery devices. Working under the supervision of the CMC Safety Executive Director and product GSO, will be responsible for device-product combination safety-related evaluations and deliverables for assigned products, worldwide. Key Activities: ?Work closely with the GSO and fully participate in GST activities related to device safety ?Support GSO and GST in specific device development safety activities and clinical interpretation of device associated safety data ?Contribute to the establishment of critical procedures and best practices related to device/combination product development and commercialization with respect to safety ?Provide content support for device/combination product evaluation activities including MDR assessments, signal detection, quality monitoring and hazard evaluations, and risk management ?For assigned products, serve as the device safety representative at selected internal meetings with collaborating Departments Knowledge and Skills ?Clinical device safety and pharmacovigilance ?Knowledge of clinical trials and device development ?Knowledge of Quality Management Systems, global safety reporting requirements, and risk management for medical devices ?Knowledge of therapeutic adra patient populations in relatin to drug-device combination products ?Familiarity with signal recognition and safety evaluation techniques ?Knowledge of global safety requirements for worldwide pharmacovigilance, especially as related to medical devices ?Excellent interpersonal and teamwork skills ?Microsoft Suite – Outlook, Word, Excel, PowerPoint ?Critical scientific thinking and problem solving ?Attention to detail ?Organizationally savvy in a matrix environment ?Time management skills ?Communication skills: presentation and medical writing ?Issue and conflict resolution Basic Qualifications ?Doctorate degree and 2 years of directly related experience OR ?Master’s degree and 6 years of directly related experience OR ?Bachelor’s degree and 8 years of directly related experience OR •Associate’s degree and 10 years of directly related experience OR •High school diploma / GED and 12 years of directly related experience Preferred Qualifications ?Drug safety, biotech/pharmaceutical or regulatory agency experience (drug delivery/combination product experience) ?Advanced scientific degree (Ph.D. or Pharm. D.) or MD or DO degree from an accredited medical school; or background in medical device development, engineering, clinical or pharmaceutical industry experience If non-physician: ?Demonstrated scientific training OR ?Clinical experience in activities relevant to utilization of medical devidces, especially as related to drug delivery If physician: ?Completion of an accredited medical or surgical residency OR ?Clinical experience in either an accredited academic setting or private practice (including hospital based) setting2012-04-19 20:54:33United StatesAmgenCalifornia15192BRCAThousand Oaks, CA28013635http://www.amgen.jobs/xml/28013635/jobUSAThousand OaksAuto req 13073BR Job Posting Title Global Safety Medical Director - Oncology Career Category Safety Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This is an opportunity for a Medical Director to serve in a Global Safety Officer GSO role within the Oncology Therapeutic area in Amgen Global Safety. The role is located at Amgen's headquarters in Thousand Oaks, California. The Global Safety Medical Director (also known as the Global Safety Officer (GSO)) leads by establishing the direction and priorities of the Global Safety Team (GST) and is accountable for all product safety related GST decisions for assigned products and is the key interface between the GST, Therapeutic Area Head (TAH), Amgen Global Safety Senior Management, and other Amgen functional areas. The GSO, supported by the Global Safety Project Manager, is responsible for the timely communication of safety recommendations and/or actions from the GST to internal and external stakeholders. This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head. Key Activities: Accountable for identification, assessment, and communication of potential safety signals as leader of GST pharmacovigilance activities GST representative on the PST (commercialization) accountable for GST PST deliverables Lead response to regulatory safety queries Lead development of strategy and creation of product risk management plans including maintenance and updates Accountable for Global Safety Strategic Plan (GSSP) Safety representative for assigned products at meetings with Regulatory authorities, data safety monitoring committees, advisory boards Participate in planning, review and sign off of clinical trial safety documents for content including: o Clinical Summary of Safety (CSS) o 120 Day safety update o Protocol safety sections o CSRs o ICFs o Study safety monitoring plans o Investigator Brochures Basic Qualifications MD or DO degree from an accredited medical school 2+ years of safety experience Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications Drug safety, biotech/pharmaceutical or regulatory agency experience Board Certification by an accredited medical or surgical board e.g. ABIM, ABMS, EUMS2011-12-23 19:32:33United StatesAmgenCalifornia13073BRCAThousand Oaks, CA25538814http://www.amgen.jobs/xml/25538814/job