Job Detail

Req #: 1900720


Location: Boudry, Neuchatel, Switzerland


Job Category: Medical


Work Location: Route de Perreux 1 2017


Organization: Drug Safety


Employee Status: Full-time


Job Type: Regular

Position: Senior Specialist, Safety Science & PASS
Supervisor: Director/Senior Director, Safety Science
Department: Global Drug Safety & Risk Management
Key Responsibilities will include, but are not limited to, the following:

General Responsibilities

• Provides effective operational and safety support to the assigned study Trial Safety Scientist (TSS) in both development and post marketing (PM) study activities


• Attend, schedule, coordinate and prepare material for TSS international meetings, as required


• Delivers efficient operational support to TSS International Team for day-to-day operations as well as ad-hoc projects as required

Trial Safety Support

• Supports and coordinates operational safety-related clinical trial activities


• Participates in ongoing SAE reconciliation between the safety and clinical databases


• Completes study-level activities: Generation of Case Management (CM) workaids, SAE report form, pregnancy report form, completion guidelines and may contribute to risk/benefit assessment for EU CTAs, protocol/CRF review and ICF Standard Risk Language review


• Coordinates and complete quarterly Trial Master File (TMF) reviews in collaboration with the study assigned TSS and ensure correct filing of GDSRM documents as per specific study TMF Index in all repositories


• Provide assistance to TSS to generate listings, DARRT requests and send safety outputs to different stakeholders for key studies as needed


• Trial Safety Science & PASS repository maintenance: Supports accurate documentation and filing of safety documents for both clinical and PM activities

Departmental Activities

• May contribute to the preparation for regulatory inspections and audits with evaluation of current processes and documentation


• May support training, trial safety overview and development of staff

Cross-Functional Activities

• May provide safety training to site and study personnel


• May support various process improvement and cross-functional initiatives for both Safety Science and GDRSM


• Interact with key line functions in support of safety activities between Safety Science and clinical R&D, Data Management, Trial Management, Medical Affairs, GCRDO and CQA

TSS international: PASS and NIS activities

• Supports study specific operational activities related to PASS


• Participates in ongoing AEs reconciliation between the safety and clinical databases


• May contribute to the review of safety sections of relevant study documents


• Generates case management (CM) workaids, AE report forms, pregnancy report forms and completion guidelines for studies


• Provides study specific training and status updates to LDSO and CM as required


• May contribute to authoring and QC content for EU PASS regional appendix of the PSUR for EMA imposed PASSs


• Provide updated GDSRM SOPs and/or WPs to CRO, as required

TSS international: Investigator Initiated Trials (IITs) activities

• May participate in IIT protocol and ICF review


• Review IIT protocols to enter into safety database protocol library and coordinate with LDSO as required


• May provide support in relation to ad hoc safety requests and inquiries from IIT study sponsors, Medical Affairs and LDSO, or escalate the issue to appropriate GDSRM colleagues


• May develop and maintain IIT support material

TSS international: General Trial Safety Support activities

• Periodic SUSAR line listings (IB quarterly and 6-monthly listings): maintain awareness of new CTA approvals, generate the SUSAR listings, liaise with case management for corrections and provide to Clinical Operations, NCAs, CROs and business partners


• Maintain associated spreadsheets, workaids and WP on periodic SUSAR listing generation


• May provide guidance and support to the LDSO for review of safety related documents and study related queries

Key Relationships

• Department staff, peers and management


• Lead Product Safety Physicians


• Clinical Operations


• Data Management


• Clinical Research Scientists/ Clinical Research Physician


• Case Management / LDSO


• Global Medical Affairs


• Clinical Quality Assurance

Governance

• Participate and/or provide input to materials and/or at meetings including but not limited to:
  
  
  
  • Study Reconciliation Team
  
  
  • SMT Safety Management Team
  
  
  • Clinical Study Team
  
  

Qualifications/Experience

Education

Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience

Relevant Industry Experience

At least 2 years of relevant pharmaceutical industry experience or equivalent training

Drug Safety Experience

1-2 yrs

Key Leadership Behaviors/Competencies

• Relationship Management


• Communication/Writing


• Time Management & Prioritization


• Results-Driven


• Self-Awareness & Perspective

About Us




COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE



At 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.