Job Title: Job ID: 13218
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.
Prerequisites:
Minimum of B.S., PharmD, or RN, or the equivalent combination of relevant education or professional experience
Seven (7) years relevant clinical experience, including scientific/medical writing
Five (5) years biotech/pharma experience, including pharmacovigilance
Summary:
To coordinate the preparation of key periodic safety reports for Celgene‘s development products
To manage periodic literature review for safety data relevant to development products
To support the Lead Product Safety MD in the assessment, communication & actions pertaining to product safety
Coordinate preparation of DSURs annually & ensure synchronization with other periodic aggregate reports as necessary
Coordinate DSUR process including establishment of timelines, project management & compilation of information from other functional areas
Obtain, coordinate & collate exposure data
Draft assigned sections of DSURs
Ensure full review, edit DSUR & respond to comments, gain approval for entire document
Response to Regulatory feedback to DSUR
Develop further evaluation & analysis
Draft document in response to regulatory questions
Risk Management Plan Development & updates
Contribute to RMP development by RMP group
Support RMP updates as applicable
Maintain Product Safety Profile
Contribute to development & maintenance of product safety profile
Contribute to theidentification & determination of Events of Interest
Process Development
Assist in identifying user requirements for various TSS reports
Work with informatics to ensure appropriateness of output from BO & other system applications
Collaborate on the drafting of key SOPs & WPs related to TSS processes
Conventions Maintenance
Contribute to establishment or updates to conventions & templates
Safety Inquiries (Internal & External)
Contribute to inquiry evaluation & determination of data required for response
Conduct search of available safety information, review relevant data & draft response
Other GDSRM activities regarding aggregate/regulatory reports
Perform other activities if capacity allows, e.g., generate prose safety narratives for CSRs, participate in submission activities (ISS, SCS, 120-day update) as necessary
Issues Management:
Contribute to the elevation of potential issues for management
Facilitate determination of nature of issue
Ensure follow-up internal notification
Execute issue management plan
Facilitate continued issue evaluation, refining plan as necessary
Review issue data and close on recommendations
Contribute to issue response document
Support communication planning
Crisis Management
Support formulation of rapid response system & corporate policy / procedure to address safety crises
Contribute to the execution of Crisis Management response plan
Responsible for:
Managing key regulatory periodic reports for development products
Analyzing data & drafting documents required for assessment & communication of product safety information
Liaising with PV/EPI group supporting approved products with continued development activities
Liaising with Regulatory Affairs to coordinate synchronization of periodic reports
Ensuring that literature is reviewed for safety data related to Celgene’s development products & forward AEs to Case Management for data entry as appropriate
Reporting literature of mechanistic / class interest to the Lead Safety Physician for consideration for presentation in aggregate reports
Posting documented searches/auto-alerts & literature articles of interest in Livelink
Drafting key SOPs/WPs/templates
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 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 "at-will" employment relationship between the employee and Celgene.
BioSpace.com - 10 months ago
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