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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.

Responsibilities:

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

EDUCATION & EXPERIENCE REQUIREMENTS:
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

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. Privacy Policy. Equal Opportunity and Diversity Policy.

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