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)

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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%)

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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.