Mark O'Connell Email and Phone Number
I am Pharmacovigilance Operations Manager with the Commercial & Study Liaison team at Amgen.Within this role I am involved in the following key areas: PSP/social digital media contract management, vendor pharmacovigilance training, Market Research review and project support.I hold an MSc. in Biotherapeutics and Business and a B.A. Mod. with second-class honours in Immunology.
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Pharmacovigilance Associate (Amgen Acquired Horizon Therapeutics October 2023)Amgen Jan 2022 - PresentDublin, 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). -
Pharmacovigilance SpecialistTcp Homecare Mar 2021 - Dec 2021County Dublin, Ireland -
Pharmacovigilance OfficerTcp Feb 2020 - Mar 2021County 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. -
SupervisorBase Wood Fired Pizza Jul 2017 - Feb 2020County Dublin, Ireland -
Undergraduate Student ResearcherTrinity College Dublin Nov 2017 - May 2018County Dublin, IrelandThesis 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. -
Lab InternTrinity College Dublin May 2017 - Sep 2017County Dublin, IrelandResearch relating to rheumatoid arthritis and the role of T cells in its pathogenesis. -
Engineering OperativeDublin Bus (Bus Átha Cliath) May 2016 - Sep 2016County Dublin, IrelandWorked as part of night crew vacuuming garage’s fleet of buses and/or refuelling the fleet.
Mark O'Connell Education Details
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Gpa: 3.4 -
Marian CollegeLeaving Certificate
Frequently Asked Questions about Mark O'Connell
What company does Mark O'Connell work for?
Mark O'Connell works for Amgen
What is Mark O'Connell's role at the current company?
Mark O'Connell's current role is Pharmacovigilance Operations Manager at Amgen..
What schools did Mark O'Connell attend?
Mark O'Connell attended University College Dublin, Trinity College Dublin, Marian College.
Who are Mark O'Connell's colleagues?
Mark O'Connell's colleagues are Steven E. James, Pe, Pmp, Philip Anderson, Leanna Gentry, Phd, Rac, Missy Jaroneski, Emmanuelle Brayda, Leandro Gentini, Megan Voorhees.
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