Celgene Drug Safety Specialist - 12 month fixed term contract in Hillingdon, United Kingdom

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

Competencies

  • Organisation and planning

  • Team work

  • Attention to details

  • Data management

  • Time management

  • Adaptability

  • Effective interactions and diplomacy

  • Promote Open Communication

  • Foster team work

  • Dealing with ambiguity

*MONEU

#LI-POST

Drug Safety Specialist - 12 month fixed term contract

Location: Hillingdon, England, UK

Job ID: 17001782