PV Officer (Medical Device & Product experience)

Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines; Performing ICSR follow up; SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review); Reconciliation (clinical, partners); Intake, triage, assessment, data entry, follow-up and processing of medical device safety / incident reports; Performing quality review/QC of medical device cases, ensuring completeness, accuracy, consistency, coding and adherence to SOPs; Personal data protection; Product Quality Complaint handling and interaction with Quality Assurance; MedDRA and WHO coding; Database Outputs and Reports (including data for monthly reporting to clients); Workflow & resource management; Mentoring and training of new and more junior employees within the department

Responsibilities

Performing activities in the scope of ICSR management unit within agreed extent and timeframe; Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines; Performing ICSR follow up; SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review); Reconciliation (clinical, partners); Intake, triage, assessment, data entry, follow-up and processing of medical device safety / incident reports; Performing quality review/QC of medical device cases, ensuring completeness, accuracy, consistency, coding and adherence to SOPs; Personal data protection; Product Quality Complaint handling and interaction with Quality Assurance; MedDRA and WHO coding; Database Outputs and Reports (including data for monthly reporting to clients); Workflow & resource management; Mentoring and training of new and more junior employees within the department

Requirements

Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance; Demonstrated experience in pharmacovigilance and medical device vigilance; Good working knowledge of EU MDR (2017/745) and medical device vigilance concepts, including seriousness, reportability, device-relatedness and regulatory reporting requirements; Experience with global/European medical device cases and safety databases; ability to identify data discrepancies and ensure cases meet required quality and compliance standards; Excellent communication (written and verbal) skills; Organization skills, including attention to details and multitasking; Delegation skills; Planning and time management; Technical skills; Team working; English – fluent (spoken, written); Advanced literacy (MS Office)