Safety Specialist

Safety Specialist

CROMSOURCE

Home-based, Italy

Job specific tasks and responsibilities:

  • Support to Company Staff for the following activities, pursuant to the terms of the applicable legislation and Company's procedures
  • Check of SAE/eSAE received in Company's sponsored Clinical trials, interacting with Clin Ops CROs, providing Company's assessment in terms of reportability/queries
  • Management of pregnancy cases
  • Management of follow- up requests to the ClinOps CROs
  • Overall SAEs monitoring and tracking
  • Interaction with the Company Global Pharmacovigilance Service Provider (PVSP) and other Company's personnel
  • Support in the preparation of documentation for SUSAR/other safety reporting submissions
  • Support in SAE reconciliation activities
  • Other activities connected with PV management in clinical trials
  • Management of other study-specific activities, pursuant to the terms of the applicable legislation and Company's procedures: revision of study specific documents, check of costs, US specific activities such as transfer of regulatory obligations, complaint management, responses to authorities, informed consent, study team meetings, kick off meetings, lessons learned, bid defense meetings, RFP preparation, CRF revision, Investigators meeting, Unblinding tool management, data review (including coding, attendance to DRM, revision of queries, ongoing review of Data Quality Reports or other sources for ongoing check), CSR revision (including narratives), Safety committees management (including charter preparation, SAC/ISMB attendance, preparation of documentation. Including MACE activities), TMF management, study specific deviations/non conformities management

Education and Experience:

  • Bachelor's degree
  • Experience in clinical research or healthcare related industry, including as a Safety Specialist
  • Working knowledge of international regulatory and ICH-GCP guidelines
  • Experience managing PV is essential

Skills:

  • Good documentation practices
  • Self-motivated and displays initiative
  • Experience of working as part of a large team with proven ability to make an active contribution to the team's performance and team working
  • Able to communicate clearly and accurately in both written and spoken English and Italian
  • Effectively collaborates with team members
  • Proven organisational skills demonstrated by the ability to understand and prioritise instructions and deliver against commitments on time
  • Proficient skills across multiple computer applications including Microsoft Office, Impact, etc
  • Attention to detail

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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