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.