Associate Director, Drug Safety Job
Location: Berkeley Heights New Jersey
Description: Celgene Corporation is at present looking to employ Associate Director, Drug Safety Job right now, this occupation will be placed in New Jersey. For detail informations about this occupation opportunity please read the description below. Post by Jobing - Troubleshooting TipsJob Title: Job ID: 14462Location: Berkeley Heights, NJOffsite Territory: Full/Part Time: Full! â€"TimeRegular/Temporary: RegularCategory: Drug SafetyDepartment: Drug Safety â€" 4202Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.Prerequisites: Minimum of B.S., Nursing; BS, Pharmacy or PharmD, or MD/ medical license or the equivalent combination of relevant education or professional experienceExperience: â€" Nine (9) years relevant clinical experience, including trainingâ€" Seven (7) years industry experience of which five (5) years is relevant to drug safetySummary: Key Activities: â€" Prov! ide safety analysis support to Lead Product Safety Physician (! LPSP) and clinical teamsâ€" Support the creation and maintenance of a single interpretation of global safety data for defined product in development (Development Core Safety Information)â€" Assist in LPSP in identifying and managing evolving safety concerns with development productsâ€" Support analysis of aggregate safety dataâ€" Provide product level oversight and surveillance supportâ€" Assist study teams in implementing, executing and concluding trialsâ€" Maintaining knowledge of safety profiles for treatment in a specific therapeutic areaâ€" Training, mentoring and coaching members of Trials Safety Surveillance to ensure individuals are effectively developed to meet business needsOutput: â€" Safety sections of trial documents (protocol, IB, IC, DMC charters, SAP)â€" DCSI or CCDS relevant sectionsâ€" Contribute to DSUR or other aggregate safety reportsâ€" Benefitâ€"risk assessmentsâ€" CSR development and reviewâ€" Summary of clinical safety/ISS generationâ€" RMP collabor! ationâ€" DMC supportâ€" Regulatory responses to safety inquiriesâ€" SOPs/WPs relevant to functionKnowledge: â€" Ability to effectively represent ideas and clinical dataâ€" Clinical knowledge of therapeutic area patient population and drugsâ€" Interpretation of aggregate safety dataâ€" Appreciation of the product development life cycle and clinical trialsâ€" Understanding of safety data capture in CT settingsâ€" Working knowledge of clinical database systemsâ€" Mastery of safety data capture, representation and interpretationâ€" Expert knowledge of the Global safety environment, international regulations and guidance documentsCompetencies: â€" Critical thinkingâ€" Able to work with minimal supervisionâ€" Communication (written and oral)â€" Scientific writingâ€" Organization and planningâ€" Ability to interpret, analyze and clearly present scientific and technical data (oral and written)â€" Team workâ€" Analytic skillsâ€" Attention to detailCelgene is committed to equal oppor! tunity in the terms and conditions of employment for all employees and ! job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.
All applicants must have authorization to work for Celgene in the U.S.Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "atâ€"will" employment relationship between the employee and Celgene.*LIâ€"JW1
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Celgene Corporation.
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This occupation starts available on: Sat, 17 Aug 2013 12:27:41 GMT