Mark O'Connell Email & Phone Number

Chicago, Il, Us

Dublin, County Dublin, Ireland

• Ensuring Horizon products are safe and in compliance with the terms of the Good Vigilance Practice (GVP) and in accordance with Horizon’s global policies and procedures.• Supporting the EU QPPV Office and the PSMF maintenance and oversight of the local QPPV network and activities.• Preparing training materials and providing training to vendors.• Tracking and oversight of Business Partners, Vendors and PV obligations in Pharmacovigilance Agreements.• Review of vendor Master Service Agreements (MSAs), Statements of Work (SOWs) and other contracts with PV-relevant vendors.• Contracts review.• SOP writing and review.• Project support: Sources of safety information resulting in introduction of new process for vendor reconciliations and audits on a risk-based approach (Mar-2022 - Sep-2023).

County Dublin, Ireland

County Dublin, Ireland

● Perform daily triage of the PV mailbox, managed the mailbox, and maintained strong communication with both my team and multiple external clients.● Ensure all activities are completed within the appropriate timeline.● Involved in processing PV events, and product quality complaints in line the organisations’ operating procedures.● Involved in carrying out regular reconciliation of case reports with internal and external sources.● Manage follow-up requests and client queries – including liaising directly with nursing teams and the patient care bureau to obtain additional information.● Be involved PV quality checks, and source data verification activities where required.● Act as a key information resource to pharmacovigilance team for training and other multidisciplinary teams.● Maintain the Pharmacovigilance reporting system as well as provide systematic reporting to in-house managers and external clients.● Ensure that the PV team are compliant with TCP SOPs, and maintain the Pharmacovigilance reporting system. This also included assisting in the development of procedures.

County Dublin, Ireland

County Dublin, Ireland

Thesis research project: “Exploring the immunomodulatory properties of nano-sized graphene flakes for tailoring biomedical applications.” This study offered new insights into the immunomodulatory effects of nano-sized graphene particles exfoliated in endotoxin-free bovine serum albumin on macrophages.

County Dublin, Ireland

Research relating to rheumatoid arthritis and the role of T cells in its pathogenesis.

County Dublin, Ireland

Worked as part of night crew vacuuming garage’s fleet of buses and/or refuelling the fleet.

Master Of Science - Ms, Biotherapeutics And Business, Gpa: 3.4

Educated on the practical uses of molecular advances in the discovery of protein and other biomolecular drug candidates and their.

Bachelor Of Arts - Ba, Immunology, 2.1

Bachelor thesis: "Exploring the immunomodulatory properties of nano-sized graphene flakes for tailoring biomedical applications". This.

Leaving Certificate