Experience

LEO Pharma UK/IE
• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Senior Pharmacovigilance Associate (dSCP)

  • Oct 2020 - Present


IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Virtual Trials Client Services Representative

  • Jul 2020 - Oct 2020

  London, England, United Kingdom

• Pharmacovigilance Specialist

  • Jul 2018 - Jul 2020

  Dublin, Leinster, Ireland Workflow Lead (WFL) •Currently Safety Operations WFL on two full service studies •Review, discuss and edit SOPs, Safety Management Plans (SMPs), protocols, data entry specifications and processing documents with management and sponsors •Project oversight and point of contact for multifunctional teams (different hubs, Clinical, Data Management) and sponsors •Generate status reports, monthly metrics to upper management and sponsors, perform data reconciliations, perform study close… Show more Workflow Lead (WFL) •Currently Safety Operations WFL on two full service studies •Review, discuss and edit SOPs, Safety Management Plans (SMPs), protocols, data entry specifications and processing documents with management and sponsors •Project oversight and point of contact for multifunctional teams (different hubs, Clinical, Data Management) and sponsors •Generate status reports, monthly metrics to upper management and sponsors, perform data reconciliations, perform study close out activities for various protocols •Ensure compliance and audit readiness •Worked with and harmonised internal processes with third party vendors Case Processor and Quality Control Specialist •Receive, triage, review, process, and perform quality control of Lifecycle Safety data (ICSRs) within safety and regulatory timelines while following regulations, SOPs and SMPs. •Generate narratives, CIOMS, MedWatch reports and AOSEs. •Generating and managing queries on all workflow steps (intake, data entry, quality control) •Experienced user of electronic databases including Argus, CTMS, Infosario, Oracle InForm, Medidata RAVE, Wingspan, Clincase, Apex, and Cenduit. Also, a proficient user of Microsoft Office 365 applications. •Indications: COVID-19, rheumatoid arthritis, B cell lymphoma, bipolar depression, schizophrenia, hidradenitis suppurativa, stress urinary incontinence, breast cancer and advanced solid tumours. •Liaise with multifunctional teams and departments to facilitate timely expedited reporting. •Focused on quality control and compliance to meet end-of-line goals Career Mentor (Lifecycle Safety) •Team player: always keep team spirits high, as a workflow lead assist in balancing workloads and troubleshooting, train and mentor current and onboarding team members from various hubs •Active member of the department employee engagement services (EES) team



Ewenique Yarnworks

• Owner

  • May 2014 - Jul 2018

  Dublin, Ireland



Oxfam Ireland

• Ireland
• Non-profit Organizations
• 1 - 100 Employee

• Volunteer

  • Oct 2013 - Nov 2016

  Dublin, Ireland



Dr. Kenneth Hun Mok Lab

• Internship

  • Jun 2015 - Aug 2015

  Trinity College Dublin Project: Determining the structure of algal ubiquitin using NMR (Nuclear Magnetic Resonance)