06 Aug, 2019
Req #: 1902608 Location: Boudry, Neuchatel, Switzerland Job Category: Medical Work Location: Route de Perreux 1 2017 Organization: Drug Safety Employee Status: Full-time Job Type: Fixed_Term Do you have a Bachelors or Masters degree, plus 6-24 months' post-graduate experience within the pharmaceutical industry? Do you have a passion for Drug Safety / pharmacovigilance? Are you seeking career development? If so, Celgene has an opening for a forward-thinking and self-sufficient individual to join our Drug Safety team - this is to help with our growing studies and to ensure that our quality control levels stay high. As Safety Data Specialist, you will work in a regional (above-country) role from our International HQ in Switzerland - this role reports to Associate Manager of Safety Data within our International Case Management Operations team. Working within an international and diverse team, this is an ideal chance to leverage your previous experience / knowledge, as well as increase your Drug Safety specialism within a stimulating and fast-paced environment,. Please note: For headcount reasons, this is a 12-month Maximum Duration contract (with the same benefits as a permanent employee) - preference will be given to candidates who are based in Switzerland already and can start by 2 September 2019 In this role, your high-level responsibilities will include: Receiving, evaluating, investigating, pre-triaging and accurately and timely data-basing all safety data Identifying and managing product quality complaints Reconciling safety data with other departments and external stakeholders Contacting primary reporters with adequate due diligence queries Performing event of special interest follow up quality check Translating source documents as needed Liaising with centralized local affiliates to ensure effective management of local operational safety activities and conformity of all case management activities with local requirements and specificities This is all with the eventual goal and purpose of: Managing safety data for all Celgene products, both from clinical trials and from post-marketing sources Conducting initial assessment of safety data and manage adequate decision making to ensure adequate and timely processing of case data Having oversight over applicable local and regional Pharmacovigilance legislation within the territory of responsibility Ensuring compliance and conformance with all applicable internal procedures and local and regional legislation Effectively managing and executing cross-functional liaison activities KEY ACTIVITIES Local Legislation and Operational Guidance Know and understand local and regional legislation and case management specificities Ensure and contribute to process conformity with legislative requirements and local specificities Act as the main point of contact for the centralized assigned LDSOs Ensure effective exchange of information on all operational and case management-related topics with assigned LDSOs Understand and contribute to adequate interpretation and process adaptation for all effective and planned Safety Data Exchange Agreements Case Management Receiving and acknowledging incoming safety data Perform initial assessment of all incoming safety data and perform duplicate check thatinitial data entry in the inbound module Identify follow-up needs and generate letters and attachments as appropriate Identify and manage Product Quality Complaints and communicate with contractual partners Coordinate translation process with agency and perform basic translations Access Eudravigilance (EMA) for NCA cases and perform literature reviews Distribute cases coming from Business Partners and IIT studies, and escalate potential incoming safety concerns Quality Activities Perform events of interest follow up quality check Reconcile safety data with QA and Medical information Contribute to and ensure compliance of inbound and due diligence activities Prepare and contribute to preparation activities for audits and inspections Process Improvement and Project Work Demonstrate knowledge of and compliance with established document management processes, guides, policies, and SOPs. Participate in mentoring and training of new staff Proactively participate in the evaluation of current processes and assess alignment with regulatory expectations, guidelines and mandates Decision Making Authority Initial assessment of all incoming safety data including but not limited to validity, case type, reporter type, seriousness, primary event coding and pre-riage decisions Determination of local and regional legislation applicability Evaluation of receipt processes and provision of recommendation Outputs Correct adverse event and special situation case report data within the central safety database Accurate and timely management of safety data in support of overall case management compliance Effective, accurate and timely safety data exchange between departments and business partners BACKGROUND Qualifications Minimum of Bachelors degree or the equivalent combination of relevant scientific and medical education or professional experience Experience 6-24 months' experience from within pharmaceutical/biotechnology industry Drug safety experience preferred Knowledge Clinical knowledge of therapeutic area patient populations and/drug class; Oncology and I&I preferred Computer and safety database skills, familiarity with global safety database preferred Working knowledge of medical terminology Understanding and working knowledge of global regulatory requirements for pharmacovigilance or related area Communication skills to effectively communicate in multi-lingual environment both with internal and external stakeholders Competencies Organisation, planning and time management Ability to work effectively in team Foster team work Attention to details Data management Adaptability and flexibility Proficient communication skills Data management and analytical skills Ability to make consistent and correct split-second decisions based on fragmented and/or complex information Solution oriented and proactive Promote open communication Dealing with ambiguity 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.
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