Vacancy caducado!
DescriptionCelgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.Key Responsibilities will include, but are not limited to, the following:General Responsibilities
Provides support to LPSP in activities relating to monitoring and management of Product's emerging safety profile
Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication
May contribute to preparation of materials (Slides, etc.) in preparation of CSC meetings
Contributes to signal detection activities by supporting review and synthesis of key safety information; Contributes to signal evaluation and tracking
Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product’s benefit/risk profile
Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g. Legal, clinical, RA, etc.)
May provide input and support safety publication strategy
Trial Safety Support
Leads execution of all operational safety-related clinical trial activities, and may serve as the Lead Safety Scientist for a compound
Supports/May lead the strategy for surveillance activities, as appropriate
Participates in ongoing SAE reconciliation between the safety and clinical databases
Completes study-level activities generation of Case Management Work aids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF
Generates SAE report form, pregnancy report form, completion guidelines for trial-related activities
Coordinates the management and preparation for DMC preparation, documentation, and logistical support
May review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR
Compound Level Safety Support
May contribute to the content of Aggregate Safety Reports (PSUR/DSUR) and Investigator Brochures in accordance with regulatory requirements and standard operating procedures
Obtains integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician for a compound
May support the lead product safety physician with the management of the product’s benefit/risk profile
Departmental Activities
Supports preparation for regulatory inspections with evaluation of current processes and documentation
Liaises with all TA staff and maintain an effective and collaborative product safety team
Supports hiring, orientation, management, mentorship, and development of staff
Cross-Functional Activities
Provides safety training to site and study personnel, and responds to ad hoc Investigator / IRB / EC Queries
Supports various process improvement and cross-functional initiatives for both Safety Science and GDRSM, which may include input to the development and periodic update of SOPs and Work Practices
Interacts with key line functions in support of safety activities between Safety Science and clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety Information Management
Key Relationships
Department staff, peers and management
Lead Product Safety Physicians
Clinical Operations
Data Management
Clinical Research Scientists
Medical Writing
Case Management / LDSO
Global Medical Affairs
Regulatory Affairs
Clinical Quality Assurance
Governance
Participate and/or provide input to materials and strategies at meetings including but not limited to:
SMT - Safety Management Teams
DMC - Data Monitoring Committees – internal or external
Clinical Study Team
Requirements/Qualifications:EducationPharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experienceRelevant Industry ExperienceAt least 4-6 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.2-4 years of Drug Safety ExperienceKey Leadership Behaviors/Competencies
Decision-Making & Change Agility
Communication/Writing
Time Management & Prioritization
Results-Drive
Self-Awareness & Perspective
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDEAt Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Vacancy caducado!