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Spec, Drug Safety

Req #: 1800901
Location: Boudry, Neuchatel CH
Job Category: Medical
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene Europe LTD
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Fixed Term
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene 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.

Drug Safety Specialist

Responsible for:

•Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised

•Initial triage of incoming AE case reports

•Assessment of AE reports

•Ensuring that individual Adverse Event Case Reports are evaluated against regulatory reporting requirements, ICH-GCP guidelines and Company SOP and procedure

•Perform submission of ICSRs to Regulatory Authorities and to third Partners within GDSRM International

•Addressing instances of technical failure of submission

•Mentoring and training of new hired safety personnel

•Workflow Management

AE Case Management 

Execute the pre-triage and triage of all incoming AE case  reports, specifically:

•Determine if "true" follow up or new case per medical & temporal criteria

•Identify and assess all AEs for seriousness and perform data entry in ARISg

•Identify pregnancy case 

•Make follow-up call if critical info needed

•Update communication module in ARISg as needed 

•Escalate report internally within drug safety as needed

Conduct the assessment of AE cases, specifically: 

•Perform QC on key fields of serious cases and update the cases as needed

•Perform case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality, generate narrative, draft company comment for serious cases, rank events, determine dechallenge / rechallange, determine follow-up needs and generate follow-up letters

•Support SDSs, Drug Safety specialists and Medical Review in their review of cases

•Review and resolve ARISg validation errors

Regulatory Reportability & Submission

•Determine regulatory reportability based on case characteristics and regulatory requirements

• Populate authority screens within the corporate safety database

•Submit ICSRs electronically and track the completion of electronic submissions

•Address instances of submission failure to development and maintenance of expedite reporting processes and procedures  and contribute to the maintenance of a regulatory reportability matrix , of distribution rules and other supporting documentation

Safety Data Specialist Support

Contribute to receipt, follow up and submission process, specifically:

•Ensure correct determination of non-AEs

•Ensure Identification of product quality reports

•Ensure effective exchange of AE case reports with third parties or other Manufacturer

•Liaise with the LDSOs to ensure effective and timely processing of AE report

•Ensure  manual submission of regulatory reports in case of technical failure

•Review & identify follow-up outside of due diligence measures

•Identify corrections and make updates in ARISg as required

Trial Safety Support

Contribute to SAE reconciliation process between clinical and safety database

Review  source documents, execute correction of serious cases   

Workflow  Management Support

Contribute to correction of Adverse Event Case Reports outside of workflow

Manage and prioritize workload

Contribute to Identification and resolution of case prioritization issues

Back up and designee of  GDSRM International  workflow manager as required

Compliance, Standards, Training & Project Management

•Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

•Contribute to review and update of SOP, WP, Work Aid

•Contribute to Inspection and audit preparation as required

•Support to regulatory enquiries

Collaboration to interdisciplinary/cross functional meetings/projects

Qualifications

Minimum of B.S. or the equivalent combination of relevant education or professional experience

Experience 

Four (4) years pharmaceutical/biotechnology industry experience

Three (3) years Drug safety experience

AE process management experience

Knowledge

•Broad understanding of global regulatory requirements for pharmacovigilance (i.e. relevant FDA, EMA and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments)

•Clinical knowledge of therapeutic area patient populations and drug class: oncology and I&I experience preferred

•Excellent working knowledge of MedDRA and WHODRUG coding dictionaries and medical terminology

•Proficiency in technical safety systems including ARISg and medical coding

•Understand utilization of aggregate safety data

•Proficiency in standard computer software and database skills

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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