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Drug Safety Specialist - 12 month fixed term contract

Req #: 17001782
Location: Hillingdon, England UK
Job Category: Medical
Work Location: 1 Longwalk Road Stockley Park UKSTOCKLEY UB11 1DB
Organization: Celgene Europe LTD
Schedule: 37.5
Shift: Day Job
Employee Status: Full time
Job Type: Fixed Term
Job Level: Individual Contributor
Travel: No
Other Locations:UK- Stockley Park

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.

Summary

  • To manage safety data within Celgene’s central safety database covering both pre- and post-market activities
  • To triage incoming AE reports to ensure their correct handling by Celgene
  • To evaluate individual case safety reports (ICSRS) and to determine regulatory reportability
  • To ensure compliance with regulatory reporting requirements

Role and Responsibilities

AE CASE MANAGEMENT

Triage

  • Execute the triage of cases
  • Determine the follow up or new case per medical and temporal criteria
  • Identify and assess all AEs for seriousness
  • Perform event/seriousness data entry into ARISg
  • Identify pregnancy case
  • Make follow up call if critical information is needed to determine AE seriousness
  • Update communication log in ARISg CCM as needed
  • Escalate report internally within drug safety as needed

Data Entry

  • Execute full data entry from source document within Celgene’s corporate safety database for developmental and marketed products

Assessment

  • Execute QC on key fields of serious cases and update ARISg as needed
  • Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
  • Identify SUSARs from blinded clinical studies and alert Drug Safety Management to the need for unblinding
  • Create narrative as defined by conventions
  • Create draft company comments for serious cases
  • Rank events and determine dechallenge/rechallenge information
  • Develop follow-up needs for AE reports and create follow-up letters, review and update generated follow-up letters as appropriate
  • Authorise (approve) non-serious cases 

Medical Review

  • Support the identification of corrections and creation of updates in ARISg following medical review
  • Discuss issues with medical reviewers as appropriate

Regulatory Reportability & Distribution

  • Determine regulatory reportability based on case characteristics and regulatory requirements 
  • Contribute to the maintenance of a regulatory reportability matrix and other supporting documentation

Regulatory Submission

  • Submit ICSRs electronically
  • Track the completion of electronic submissions and address instances of submission failure

Trial Safety Support

  • Contribute to SAE reconciliation process between clinical and safety database
  • Review  source documents, execute correction of serious cases

INTERNAL GLOBAL SAFETY DEPARTMENT DEVELOPMENT

  • Contribute to the hiring, orientation, training and development of staff as needed
  • Facilitate the interpretation and tracking of regulatory requirements for drug safety
  • Contribute to conventions and process documentation as required
  • Support continuous improvement of processes and safety database

Qualifications

Minimum of B.Sc or a Nursing Qualification or the equivalent combination of relevant education or professional experience

Skills and Experience required

  • Relevant experience in the Industry; Drug Safety experience required
  • Clinical knowledge of therapeutic areas - Oncology and Inflammation and Immunology experience is preferred
  • Computer and  safety database skills; Familiarity with the ArisG safety database is preferred
  • Working knowledge of MedDRA and WHODRUG coding dictionaries and medical terminology
  • Working knowledge 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

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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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