Drug Safety Assistant

Elevate Direct
High Wycombe
10.00 - 13.00 GBP Hourly
12 Feb 2019
19 Feb 2019
Contract Type
Full Time

Execute drug safety support activities as required for Marketing Authorisation Holders (MAH's) and/or study sponsor, as applicable to ensure Janssen-Cilag complies with Good Pharmacovigilance Practice regulation.


  • Answer inbound calls from general public, HCPs, internal colleagues to elicit and capture relevant adverse event data
  • Enter relevant/required safety data into the Global Safety Database from various sources
  • Request additional information from multiple sources, both internal and external to the company
  • Confirm that requests for additional follow-up has been sent to reporters as appropriate through review of due diligence reconciliation reports and monitoring that due inbox
  • Support TFUP questionnaire reconciliation
  • Monitor due diligence schedule process
  • Clinical scan and attach files into sceptre
  • Review case files and/or processes as directed to support internal and external audits and inspections
  • Complete all assigned training in a timely manner
  • Administers the due diligence process to ensure completeness of case reports and timely distribution of follow-up requests
  • Loose filing and IRT processing
  • Files maintains and archives all case materials, including original source documentation
  • Support CSTL/LSO in responding to ad hoc requests


  • Awareness of and familiarity with medical terminology
  • Proficiency in global and local SOPs
  • Computer literate with expert knowledge of the Global Safety Database
  • Ability to prioritise and work to strict timelines on a daily basis
  • Excellent verbal and written communication skills
  • Ability to communicate with internal and external customers
  • Ability to work effectively as a member of the Drug Safety and broader Medical Department teams
  • Previous experience in a similar/related role
  • Degree-level qualification in life science or equivalent experience

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

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