Senior Drug Safety Officer, home based

☞ TFS

View: 103

Update day: 11-06-2024

Location: London

Category: Pharmaceutical / Chemical / Biotech

Industry: Pharmaceutical Biotechnology

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Job content

Position can be based in one of TFS office in Europe, or in the US.
  • Manage the handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing demands of the authorities
  • Review and approval of processed cases and AE/SAE reconciliation
  • Coding of adverse event, medical history and concomitant medication according to MedDRA and WHO-Drug Dictionary
  • QC and approval of coding of adverse event, medical history and concomitant medication
  • Review and write the safety section in clinical study protocols
  • Review of clinical trial reports/IBs from a safety perspective
  • Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents
  • Literature search
  • Electronic reporting to EudraVigilance
  • Responsible for plans/instructions and SOPs for post approval surveillance
  • Updating of templates for safety handling in specific studies/projects according to relevant SOPs
  • Act as a Project Lead for Safety-only projects
  • Overlook that assigned projects and tasks in the unit are done in accordance with current routines, methods, SOPs (TFS or client´s) and existing demands of the authorities
  • Responsible for safety database life cycle including validation, migration, database setup processes, system retirement, periodic review, change management and user acceptance test writing with respect to drug safety regulations, SOPs.
  • Being well-informed and updated on laws, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues.
Requirements:
  • Bachelor’s Degree, preferably in life science or nursing; or equivalent
  • 5 years of relevant experience
  • Able to work in a fast-paced environment with changing priorities
  • Understand the medical terminology and science associated with the assigned drugs and therapeutic areas
  • Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
  • Ability to work independently as well as in a team matrix organization with little or no supervision
  • Excellent written and verbal communication skills
  • Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus
Benefits:
Benefits available to employees in the United Kingdom:
  • Private Health Coverage
  • Corporate Pension Plan
  • Life Insurance
  • Global General Liability Insurance
  • Global Travel Insurance
  • Home-based Allowance
  • Internet reimbursement
  • Flexible working schedule
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Deadline: 26-07-2024

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