Associate Director, Safety Scientist Job occupation at Celgene in Berkeley Heights

Celgene is at present recruited Associate Director, Safety Scientist Job on Mon, 14 Oct 2013 06:02:47 GMT. Associate Director, Safety Scientist Job Troubleshooting Tips Job Title: Job ID: 14802 Location: Berkeley Heights, NJ Offsite Territory: Full/Part Time: Full-Time Regular/Temporary: Regular Category: Drug Safety Department: Drug Safety - 4202 Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical...

Associate Director, Safety Scientist Job

Location: Berkeley Heights New Jersey

Description: Celgene is at present recruited Associate Director, Safety Scientist Job right now, this occupation will be placed in New Jersey. Further informations about this occupation opportunity kindly read the description below. Troubleshooting Tips

Job Title:
Job ID: 14802
Location: Berkeley Heights, NJ

Offsite Territory: Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Drug Safety
Department: Drug Safety - 4202

Celgene 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.

• B.S or PhD in a biological science, BS Nursing, BS Pharmacy or PharmD, or the equivalent combination of relevant education or professional experience.
• Six (6) years relevant experience, including training. Seven (7) years industry experience of which five (5) years i! s relevant to drug safety

Summary:

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• Provide safety analytical support to the Lead Product Safety Physician (LPSP)
• Support the creation and maintenance of a single interpretation of global safety data for marketed products
• Assist in identifying and managing evolving safety concerns with marketed products
• Support signal detection and analysis of aggregate safety data
• Maintaining knowledge of safety profiles for treatments in the hematology/oncology therapeutic area

Outputs:

• Analyze data for use in internal/external reviews, periodic reports and quality reviews
• Draft regulatory responses to safety enquiries
• Analyze signal detection outputs and draft reports
• Literature Reviews
• Draft abstracts/publications and slide decks
• Draft Safety Topic reviews / other Safety summaries
• Company Core Data Sheet / Product Labelling updates
• Collaboration on Risk Management Plans
• Agendas, ac! tion items, minutes
• SOPs/WPs pertaining to drug safety

Knowledge:

• Knowledge of international global regulations and guidances pertaining to drug safety
• Knowledge of Industry principles of drug safety, drug development, pharmacology, biostatistics and pharmaco-epidemiology.
• Knowledge of signal recognition and statistical techniques
• Assessment, interpretation & presentation of aggregate safety data
• Knowledge of commercial drug environment
• Knowledge of oncology/hematology patient populations and drug classes
• Experience with safety-related risk management, in particular signal confirmation, health hazard assessments, and/or risk mitigation.
• Working knowledge of safety database systems
• Mastering of safety data capture in clinical trial and post-marketing settings
• Knowledge of MedDRA Medical Coding principles

Competencies:

• Critica! l thinking
• Organization and planning
• Communication (o! ral and written)
• Data extraction
• Attention to detail
• Ability to interpret, analyze and clearly present scientific and technical data (oral and written)
• Able to work with minimal supervision
• Team work
• Ability to thrive in a global matrix environment

Celgene is committed to equal opportunity 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 fo! r 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 "at-will" employment relationship between the employee and Celgene.

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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Celgene.

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This occupation starts available on: Mon, 14 Oct 2013 06:02:47 GMT

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