Connecting...

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9wyxjrlxn0cmvldc1wzw9wbguvanbnl2jhbm5lci1kzwzhdwx0lmpwzyjdxq

Drug Safety Data Specialist | 6-month contract

MarkerUxbridge Coin£25.00 to £28.00 per hour

Vacancy summary

Reference: 08391

Job Type: Contract

Date Posted: 8 August 2019

  • Join a global Pharmaceutical company
  • Use your PV skills to contribute to oncology drug development on post-marketing activities
  • Be part of a great team within drug safety

Drug Safety Data Specialist | 6-month contract

This is a great opportunity for a Drug Safety Data Specialist to join a global pharmaceutical company to work on both pre-and post-market activities in clinical trials. To be successful in this role, you will need to have prior experience in both pharmacovigilance case processing and reporting.

As a Drug Safety Specialist within this innovative organisation, you will be delivering adverse events and writing reports. Located on the outskirts of West London you will be part of a team of pharmacovigilance specialists, working on clinical trials, ensuring regulatory reporting compliance.

KEY RESPONSIBILITIES:

  • Manage the release of individual case reports from the drug safety department
  • Co-ordinate the receipt and management of adverse event (AE) reports
  • Complete event data entry and assessment into ARISg
  • Non-serious AE case processing and evaluation
  • Managing the final stages of case reports
  • Upholding submission details within the corporate drug safety database
  • Maintaining case files to include source documentation and submission records where applicable
  • Maintain compliance, such as SOPs
  • Case management and co-ordinate the receipt of case reports
  • Tracking and distributing of tracking of follow-up materials
  • Determination of non-AEs including the initial receipt and data entry of AE and non-AE case reports

 

REQUIREMENTS:

  • Life science/Pharmacy degree ideally
  • Previous experience in drug safety / pharmacovigilance data management
  • Excellent attention to detail and ability to ensure documents are properly filed and stored
  • Attention to detail
  • Time management
  • Word processing experience
  • Ability to work independent and as a part of the team
  • Strong communication skills

 

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.

Drug safety specialist, drug safety, pharmacovigilance, Safety Data, clinical trials, FDA, EMA, ICH guidelines, Adverse event, non-serious adverse event, AE, ARISg

Want to earn up to £500? *
*Terms and conditions apply


Similar jobs to consider