Medical Safety Lead (Remote)

at  Hobson Prior

Mechelen, Vlaanderen, Belgium -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate08 Jul, 2024Not Specified09 Apr, 20241 year(s) or aboveClinical Trials,Immunology,OncologyNoNo
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Description:

BBBH25063

Hi I’m
Terrah-Leigh
, I manage this role
Hobson Prior is currently seeking a Medical Safety Lead for a contract role. This position will focus on global pharmacovigilance activities related to the investigational products portfolio. The successful candidate will be involved in the review and analysis of safety data from non-clinical and clinical trials, quality control of individual case safety reports (ICSRs), and the identification and management of safety signals.
Please note that to be considered for this role you must have the right to work in this location.

REQUIREMENTS

  • Must hold an MD degree or equivalent (e.g., DO or MB).
  • Prior experience in Oncology is strongly preferred, and experience in Immunology would be advantageous.
  • Previous experience in phase 1 to 3 clinical trials is strongly preferred.

Responsibilities:

  • Oversee global pharmacovigilance activities for investigational products, including review and analysis of safety data from non-clinical and clinical trials.
  • Ensure quality control of individual case safety reports (ICSRs).
  • Identify and manage safety signals and manage the benefit-risk profile of assigned compounds.
  • Provide scientific review of internal and external documents.
  • Manage external service providers delivering pharmacovigilance services.
  • Perform medical review and provide medical advice.
  • Chair regular meetings of the Safety Management Teams.


REQUIREMENT SUMMARY

Min:1.0Max:3.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Mechelen, Belgium