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Drug Safety Scientist

Location: High Wycombe, Buckinghamshire Salary: £25.00 - £30.00 per hour
Sector: Pharmaceuticals Specialism:
Type: Contract Contact: Matt Henocq

Drug Safety Scientist

The role is to support and coordination of safety reporting requirments as required for Marketing Authorisation Holders (MAHs) and or study sponsor applicable.


Inbound Case Management:

  • Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
  • Entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
  • Provision of safety information/acknowledgement to marketing partners/other third party
    partners/Global Medical Safety within the internal and contractual timelines
  • Requesting additional information from multiple sources, both internal and external to the Company
  • Assist with assessment of incoming information from multiple sources, both internal and external to the Company
  • Assist in the quality review of data captured in the Global Safety Database 40

Outbound Case Management:

  • Continual monitoring and assessment of reportability of Individual Case Safety Reports due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and Notified Bodies (British Standards Institution (BSI))
  • Quality review of expedited assessments prior to submission
  • Provision of safety information to Competent Authorities/Notified Bodies within required regulatory timelines 40

Additional Activities

  • Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
  • Support all occurrences of internal and external audits and inspections
  • Ensures all assigned training is completed in a timely manner
  • May be involved in mentoring/training of Janssen staff and/or third party partners with respect to pharmacovigilance
  • May be involved in completion of periodic reconciliation activities
  • May be assigned as key contact for studies or partner contracts
  • Support CSTL / LSO in responding to ad hoc requests as required 20

Essential Knowledge & Skills

  • Awareness of and familiarity with industry principles of drug development and pharmacology
  • Proficiency in global and local SOPs
  • Computer literate with expert knowledge of the Global Safety Database and/or expedited reporting module(s)
  • Ability to prioritise and work to strict timelines on a daily basis
  • Excellent verbal and written communication skills
  • Ability to negotiate and communicate with internal and external customers
  • Ability to work effectively as a member of the Drug Safety and broader Medical Department teams
  • Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland

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