Drug Safety Assistant

Recruiter
Elevate Direct
Location
High Wycombe
Salary
10.00 - 13.00 GBP Hourly
Posted
12 Feb 2019
Closes
19 Feb 2019
Contract Type
Contract/Interim
Hours
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.

PRINCIPAL RESPONSIBILITIES:

  • 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

EDUCATION & EXPERIENCE REQUIREMENTS:

  • 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

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email as soon as possible. Once the application process is completed within Elevate, your application will then visible to the hiring recruiter. If you don't complete the process in Elevate you will not be visible to the recruiter or hiring manager.

If you have any problems at all with the process you can contact the Elevate support team at any time(see below)