Vigilance Officer

Salary: €62,248 - €84,391 per annum pro rata for part time/short term roles

Main Purpose of Job

The Pharmaco-device Vigilance Officer works as part of a multi-disciplinary team within the Institute for Clinical Trials within the HRB-CRFG and CORRIB Clinical Trial units.

Establish and maintain Device Vigilance and Pharmacovigilance processes that support the activities of the HRB-CRFG and CORRIB as a delegate of the Sponsor in relation to Clinical Trials and Clinical Investigations. The role will establish safety oversight processes for clinical trials across all study phases. The person in this role will be the primary point of contact for vigilance-related queries and issues pertaining to Sponsor oversight functions.

The Pharmaco-device Vigilance Officer supports the associated study teams in ensuring Adverse Events and device deficiency reports are processed in an accurate and timely fashion in accordance with regulatory requirements, and ensures that the Sponsor (University of Galway or external sponsor) is informed in a timely and accurate fashion of safety issues, to safeguard the interests of patients and healthcare professionals while complying with legal/regulatory requirements concerning adverse event monitoring and reporting.

The Vigilance Officer manages the overall evaluation of vigilance data received and identification of potential vigilance issues; implements risk management strategies in HRB-CRFG and CORRIB to ensure studies are appropriately monitored in terms of safety and onward reporting; and develops, implements and maintains systems to assure the quality of clinical research undertaken within HRB-CRFG and CORRIB is in accordance with all relevant regulations and standards.

Main Duties and Responsibilities

The Pharmaco-device Vigilance Officer will:

• Interpret complex legislation as applies to safety and vigilance for clinical research studies, identifying the implications for HRB-CRFG/CORRIB operations and act to initiate necessary changes to practice in order to ensure that HRB-CRFG/CORRIB remains compliant with statutory regulations at all times.

• Maintain systems and processes to ensure that pharmaco/device-vigilance practices for University of Galway-sponsored clinical studies that are conducted through the HRB-CRFG and CORRIB are conducted in accordance with ICH GCP guidelines, the Clinical Trial Directive/Clinical Trial Regulation (as applicable), Medical Device Regulation, ISO 14155 and all relevant legislation and standards.

• Liaise with the sponsor to ensure that all requirements are met in terms of safety monitoring, assessment and onwards reporting.

• Develop mechanisms for risk assessment of sponsored clinical studies from the point of view of pharmaco/device vigilance to ensure that any high-risk areas are mitigated prior to the study opening and throughout the course of the study.

• Guide and assist with the production of periodic safety update reports (e.g. DSUR) and other interim reports as required (e.g. DSMB).

• Prepare and send periodic progress reports to the Regulatory Authorities, Sponsor and University of Galway Clinical Research Development Office, as required.

• Undertake EudraVigilance or EUDAMED registration on behalf of University of Galway as Sponsor, as required.

• Act as the Pharmacovigilance contact person for sponsor-affiliates, internal staff and project managers.

• Provide professional advice to CIs/PIs in relation to safety monitoring and reporting in the conduct of clinical research.

• Handle collection, submission and filing of safety data from study event reports, spontaneous reports and reports from literature for studies where the Sponsor oversees these duties.

• Lead with the preparation and maintenance of Pharmacovigilance documentation and SOPs.

• Liaise with Clinical Research personnel in the preparation of safety data required in support of the clinical research programme.

• Respond to all medical and technical enquiries accurately and in accordance with current opinion/knowledge, the published literature and HRB-CRFG and CORRIB in-house expertise.

• Ensure that all medical information queries from both University of Galway and external stakeholders are handled accurately and in a timely manner.

• Maintain regular contact with external personnel reporting adverse drug reactions or making medical information enquiries and with regulatory authorities as required, in addition to both University of Galway and HRB-CRFG and CORRIB associates.

• Undertake continuous monitoring and review to ensure accuracy and quality of output processes.

• Maintain references and other medical information resources.

• Provide Pharmacovigilance training to internal staff and external partners, as required.

• Budget development support for device vigilance or pharmacovigilance.

• Support preparation for audit or inspection and present as subject matter expert as required.

• Carry out other appropriate and relevant duties under the direction of the HRB-CRFG and CORRIB Directors, Programme Managers and Sponsors that arise during the ambit of the post.

Requirements for the Role

The successful candidate will demonstrate the eligibility requirements below in terms of qualification, skills and experience:

Essential Criteria

• Degree level qualification in a medical, clinical, scientific, or related field from an accredited institution.

• Prior vigilance experience in clinical studies. Knowledge of Good Clinical Practice as outlined per ICH GCP and ISO 14155.

• Experience in developing vigilance strategies and safety data management.

• Proven project management and organisational skills.

• Self-motivated and able to work independently, showing initiative and good judgment.

• Good data management and IT skills. Proficient in basic software packages e.g. MS Office.

• Fluent in English, possess excellent written and verbal communication and interpersonal skills.

Desirable Criteria

• Experience gained working in a vigilance role (device vigilance and/or pharmacovigilance) for a sponsor in a commercial (e.g. CRO, pharma or medical device) or academic setting.

• Experience working within a quality management system adhering to QC and QA control systems and risk management processes.

• Qualification in pharmacovigilance or related discipline leading the development of safety plans and strategies for safety oversight of clinical study execution.

• Postgraduate qualification in clinical research or other life science or engineering-related subject.

• Understanding of MedDRA and device vigilance coding.

• Familiarity with medical and therapeutic area knowledge terminology.

• Understanding of EudraVigilance and EUDAMED reporting processes.

• Clinical research data management experience.

• Experience working with EDC systems for data capture and design of safety case report forms.

• Good Clinical Practice training.

• Experience adhering to applicable regulations, guidelines and legislation for clinical trials.

• Experience in trial management software packages and/or databases.

• Excellent communication skills (oral, written & presentation) with proven ability to work effectively as part of a team.

• Strong leadership and communication skills.

The above criteria will be utilised to shortlist and select candidates for interview.