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Combination Product Safety Medical Director, US- Remote

Company: Amgen
Location: Thousand Oaks
Posted on: January 12, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Combination Product Safety Medical DirectorLiveWhat you will doGroup PurposeProvide science-based evaluation of product quality and combination products, stand-alone devices, diagnostics and digital health safety issues for Amgen productsAssess of potential impact of quality findings on patient/user safety for all clinical and commercial productsReview of adverse event data to detect potential product quality issues for commercial productsProvide expertise in combination product safety data collection / analysis / reporting in clinical trials, post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit / risk analysesJob SummaryThe Combination Product Safety Medical Director is the safety expert for assigned combination product this includes:Assessment of potential impact of quality findings on patient/user safety for all clinical and commercial products in conjunction with members of the Global Safety TeamProvide clinical input for combination product scientistsProvision of expertise for combination product safety data collection/analysis/reportingProvision of expertise for combination product risk management activitiesKey ActivitiesCombination Product SafetyAssesses and manages combination product safety issuesCreates input for combination product risk management documents (hazard analysis, user risk assessments, human factors, etc.) for clinical and commercial productsCreates reportability assessment activities take place for device complaints/malfunctionsProvides clinical input in the development and maintenance of digital health technology assetsProvides medical oversight to CPS staff for the combination product risk/benefit analysesProvides clinical input for medical evaluationsInspection ReadinessUndertakes activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessActs as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibilityGeneralPerforms management activities for direct reports including mentoring, career development, training, etc.Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisorKnowledge and SkillsKey CompetenciesProcesses and regulations for pharmacovigilance and risk management in addition to combination products and stand-alone devices.Advanced understanding of interfaces across various pharmacovigilance and risk management processesDrug/device development and lifecycle managementSafety data capture in clinical development and post-market settingsSafety database structure and conventionsMedDRA and other dictionaries used in pharmacovigilance and device reportingMethods of qualitative and quantitative safety data analysisProduct and disease state knowledgeGeneral medicine, epidemiology, physiology, and pharmacologyInternal organizational and governance structureInter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labelingPharmacovigilance skillsSignal detection and evaluationAggregate data analysisGood clinical and scientific judgmentApplication of medical concepts and terminologyDocument writing and source document reviewData interpretation and synthesisBasic skills in application of statistical and epidemiological methods to pharmacovigilanceAbility to convey complex, scientific data in an understandable wayAbility to analyze and interpret complex safety dataAdvanced skills in application of statistical and epidemiological methods to pharmacovigilanceOther skillsStrategic thinkingEffective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environmentBig picture perspective and context analysisPeople and team managementConflict managementOrganization, prioritization, and planning of workProject managementCritical scientific assessment and problem solvingOral presentation skillsWritten communications and medical/scientific writingComputer skills (e.g., MS Office Suite and safety systems)CompetenciesKNOWLEDGEServes as a technical authority within the organizationDevelops advanced/leading-edge technologies and/or concepts that have global reach and applicabilityProblem solvingApplies global thought leadershipShapes long-term strategic direction and reputation of AmgenProvides authoritative advice to top managementLeads organizational invention at a global levelAutonomyModels organizational standards for innovationDirects projects of critical importance to AmgenContributionServes as expert advisor to top management and is a sponsor for large-scale projectsEnsures products and services are aligned with current and future needs and expectations including the following:Business needsMedical fieldResearch communityCreates solutions that enhance Amgens intellectual propertyWinWhat we expect of youEducation & Experience (Basic)MD or DO degree from an accredited medical schoolCompletion of an accredited medical or surgical residency5 years experience in drug safetySignificant (3 years+) experience with combination product safetyEducation & Experience (Preferred)MD, DO, or equivalent degree from an accredited medical school4 years of directly related experience OR MD of a foreign medical schoolAndProduct safety in the bio/pharmaceutical industry or regulatory agencyPrevious management and/or mentoring experienceClinical experience in either an accredited academic setting or private practice (including hospital based) settingThriveWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply now for a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comJoin UsIf 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.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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Thousand Oaks , Combination Product Safety Medical Director, US- Remote, Executive , Thousand Oaks, California

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