Mark O'Connell

Mark O'Connell Email and Phone Number

Pharmacovigilance Operations Manager at Amgen. @ Amgen
thousand oaks, california, united states
Mark O'Connell's Location
Ireland, Ireland
About Mark O'Connell

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.

Mark O'Connell's Current Company Details
Amgen

Amgen

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Pharmacovigilance Operations Manager at Amgen.
thousand oaks, california, united states
Website:
amgen.com
Employees:
27715
Mark O'Connell Work Experience Details
  • Amgen
    Pharmacovigilance Associate (Amgen Acquired Horizon Therapeutics October 2023)
    Amgen Jan 2022 - Present
    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).
  • Tcp Homecare
    Pharmacovigilance Specialist
    Tcp Homecare Mar 2021 - Dec 2021
    County Dublin, Ireland
  • Tcp
    Pharmacovigilance Officer
    Tcp Feb 2020 - Mar 2021
    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.
  • Base Wood Fired Pizza
    Supervisor
    Base Wood Fired Pizza Jul 2017 - Feb 2020
    County Dublin, Ireland
  • Trinity College Dublin
    Undergraduate Student Researcher
    Trinity College Dublin Nov 2017 - May 2018
    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.
  • Trinity College Dublin
    Lab Intern
    Trinity College Dublin May 2017 - Sep 2017
    County Dublin, Ireland
    Research relating to rheumatoid arthritis and the role of T cells in its pathogenesis.
  • Dublin Bus (Bus Átha Cliath)
    Engineering Operative
    Dublin Bus (Bus Átha Cliath) May 2016 - Sep 2016
    County Dublin, Ireland
    Worked as part of night crew vacuuming garage’s fleet of buses and/or refuelling the fleet.

Mark O'Connell Education Details

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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