Vigilance Associate - Pharmaceutical

Posted 08 June 2024
Salary Negotiable
Job type Full Time
Discipline Clinical & Data
Contact NameSiobhan Mcloughlin

Job description

Mantell Associates is partnered with a Pharmaceutical organisation in their search for a Vigilance Associate, to focus on Drug and Device Vigilance.

Vigilance Associate - Responsibilities:

  • Ensuring that all vigilance activities are conducted in accordance with internal SOP's, Good Vigilance Practice, MDR and regulatory requirements
  • Be a point of contact for Vigilance activities
  • Perform case intake, processing and reporting (ICSR & MIR) and reconciliation with distributors
  • Perform local and global literatures search and review (EVWEB/MLM/MHRA)
  • Perform regulatory intelligence activities
  • Perform periodical updates of EU and UK PSMF (Pharmacovigilance System Master File)
  • Perform signal management activities
  • Review and update Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Support with updating the Safety Reporting Plans (SRPs) and Incident Reporting Requirements
  • Support with creation and updating of SDEAs (Safety Data Exchange Agreements) and MDVAs (Medical Device Vigilance Agreements)
  • Safety database management and maintenance
  • Support with Field Safety Corrective Actions/Recalls process together with internal departments
  • Ensure compliance of reporting activities with timelines and criteria
  • Support with Vigilance audit-related activities (audits planning's, communications, audit record registration in Veeva, ensuring CAPAs are set on time in Veeva and follow-up on CAPA closures)

Vigilance Associate - Requirements:

  • Minimum of Bachelor Degree in Biology, Pharmacy, BioMedical Science, Physics, Chemistry, or a related discipline
  • Previous experience in pharmaco- and device vigilance is an advantage
  • Knowledge of MDR, ISO13485, GDP, GMP, Drug regulation/directive, GVP modules knowledge is an advantage
  • Be able to work with MS Office (Excel, Word, PowerPoint & Outlook)
  • Fluent in English (Spoken and written)
  • Ability to travel for audits (5 -10%)

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.