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.