jude oghoro
Northampton,Northamptonshire
Summary
Highly skilled professional with extensive expertise in pharmacovigilance, adept in using ARGUS, ARISG, SCEPTRE, and ITRACK databases. Demonstrates strong leadership and project management skills, coupled with excellent verbal and written communication abilities. Proven track record in negotiating and communicating with internal and external stakeholders, ensuring compliance with key legislations applicable to pharmacovigilance. Experienced in submitting case reports to regulatory authorities and other relevant bodies. Possesses a solid understanding of the National and International Pharmaceutical ABPI codes, signal detection, risk assessment, and internal audit skills within the Quality Management System (ISO 9001:2015). Committed to self-motivation and effective decision-making to drive organisational success.
Overview
10
10
years of professional experience
Work history
PV OPERATIONS, ONCOLOGY and VACCINE SUPPORTED STUDY LEAD
GLAXOSMITHKLINE(GSK)
Brentford
07.2022 - 11.2023
- Study Team leader for all vaccines supported project from start to close out
- Co-ordinating set-up of studies including the review of study documents such as protocols, contracts, Clinical Trial Applications etc, safety slides, AE/SAE forms, Kick off Meetings attendance for all Global vaccine supported studies
- Review of Global Safety Management Plans (SMP), Data Management Plans (DMP), Protocol Data Entry Guidelines (PDEGs) and completion of start-up/close out checklists
- Preparation and submission of safety database configuration requests, reviews UAT outputs for Electronic Data Capture (EDC) and SDB, assists the study lead in vendor training
- Managed group of 4 under Vaccine support projects/studies
- Co-ordinating spot checks in JIRA to ensure relevant documents have been filled appropriately for vaccine supported studies
- Leading on oversight of study reconciliation activities and escalations to other study leads, as needed
- Supporting all aspects of case handling activities from case receipt to expedited reporting and collaborates with stakeholders (i.e
- The Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations
- Reviews and maintains oversight of training materials developed by third parties/vendors
- Monitors key performance indicators (KPIs) generated from supplier and quality organizations, determines appropriate responses to manage and mitigate risk, and identifies issues for escalation/action as required
- Maintains awareness of EMA/FDA/CRO/licensing partner reporting rules and ensures case handling is performed in alignment with reporting timelines and expectations
- Manages PV Operations mailboxes for Spontaneous and Clinical Trial queries and responds to allocated queries in a timely manner
- Demonstrates GSK values during interactions
SENIOR PV SPECIALIST
PROPHARMA GROUP
Richmond
12.2021 - 06.2022
- Team Leader for ICSR Cancer(Oncology) therapeutic area
- Managed PV cases through call intake, documentation, and case processing
- Managed assigned PV Scientists
- Perform initial assessment of serious, expectedness, causality and reportability of adverse events for Junior PV Scientist
- Performed case quality checks and signal detection activities
- Engaged in Client interactions for reconciliation purposes and review of projects
- Manage Deviations and CAPAs
SENIOR SAFETY ASSOCIATE(IPV)
BIOGEN LTD
Maidenhead
07.2021 - 12.2021
- Assist all PV projects for post marketing and clinical trials
- Clinical drug safety endpoint management and data safety monitoring
- Stakeholders/Vendors/Suppliers and external HCP liaison communication for compliance, quality and operational excellence through reconciliation of projects
- Safety Data Exchange Agreement(SDEA) extensive management of Stakeholders/Vendors
- Oversight of New vendors/Biogen staff inclusion into Biogen data bases
- Management of PV quality documents
- IPV support in terms of technology and Job aids requirements
- Maintain PV team training matrix, training folders and training records
DRUG SAFETY ASSOCIATE
PRA HEALTH SCIENCES
Reading
01.2021 - 07.2021
- Tracking/Entry of ICSR into client safety Database
- Generate Concise, accurate and well-written case narratives
- Aggregate reporting and Literature review
- Performs consistent coding of diseases, adverse events, and medications according to project-specific coding conventions in safety Database
- Managed/Supervised the training of 4 PV Scientists in Global case management and Reconciliation with third parties/Vendors
IPV CASE MANAGEMENT SPECIALIST
JOHNSON AND JOHNSON FAMILY GROUP OF COMPANY
High Wycombe
04.2019 - 10.2020
- Case processing activities such as Data entry, Narrative and QC
- Compliance activities of inbound cases to triage /allocation of cases
- Training, case review, on-going support and oversight on case level for VENDORS such as IQVIA as and when required
- Managed all types of periodic reconciliation activities with vendors and clinical trial sites
- Communication with Medical information and QA teams regarding Device/PQC related adverse events
- Audit/inspection support
- Ensures accurate and timely documentation of Deviations to process/timelines including root cause analysis and documentation of CAPA as applicable
- Manage Global IPV case management team in Europe, Africa and parts of Asia(India and Japan)
PATIENT SAFETY SPECIALIST ON BEHALF OF ALCON, UK & IRELAND
NOVARTIS PATIENT SAFETY
Camberley
07.2018 - 04.2019
- Quality checks of ICSR
- Case management of AEs of Visioncare and Surgical Alcon patients
- Reconciliations of cases and submission of reports to MHRA
- Alcon Visioncare and Surgical samples processing
- Audits participation
- CAPA
- Medical information team Support
PHARMACOVIGILANCE OFFICER
HEALTHCARE AT HOME
Burton
10.2017 - 05.2018
- Case processing
- Tracking/reporting of adverse events to Pharma clients and MHRA
- Reconciliation of reports and acknowledgements/receipts returned by Pharma/MHRA
- Review of source verification data and prepare reports as required
- Quality assurance processes of HAH Outpatient Treatment
- Training of new pharmacovigilance officers according to HAH SOPs and use of HAH data base systems
- Strict adherence to timelines regarding targets
- Knowledge of Signal Detection
DRUG SAFETY EXECUTIVE
CROWN PHARMACOVILANCE LTD
Hainault, Essex
03.2016 - 07.2017
- ICSR management and case control
- Coding verbatim events using MedDRA database
- Literature review
- Submission of adverse events to relevant authorities/PSUR training/ SDEA support
Pharma Operations Officer / Adverse Events Lead
ALCURA HEALTHCARE LTD
Northampton
09.2013 - 03.2016
- General adverse drug reactions query from customers to ensure drug safety
- Pharmacovigilance awareness training of returned drugs to Alcura
- Medical information assist
Education
INTERNAL AUDIT CERTIFIED(ISO 9001:2015)- FEB 2019 -
Dip clinical pharmacy practice - undefined
Robert Gordon University
2012
Dip - undefined
London Training College
2009
B.Pharm - undefined
University of Benin
2000
Skills
- SKILLS/COMPETENCES
- ARGUS, ARISG, SCEPTRE and ITRACK database skills
- Leadership skills
- Project management skills
- Excellent verbal and written communication skills
- Ability to negotiate and communicate with internal and external stakeholders
- Knowledge and understanding of key legislations applicable to pharmacovigilance
- Submission of case reports to Regulatory authorities and other relevant bodies
- Basic knowledge of the National and International Pharmaceutical ABPI codes
- Ability to demonstrate self-motivation and effective decision making
- Knowledge of Signal detection and Risk assessment
- Internal Audit Skills(Quality Management system-ISO 9001:2015)
References
References available upon request.
Timeline
PV OPERATIONS, ONCOLOGY and VACCINE SUPPORTED STUDY LEAD
GLAXOSMITHKLINE(GSK)
07.2022 - 11.2023
SENIOR PV SPECIALIST
PROPHARMA GROUP
12.2021 - 06.2022
SENIOR SAFETY ASSOCIATE(IPV)
BIOGEN LTD
07.2021 - 12.2021
DRUG SAFETY ASSOCIATE
PRA HEALTH SCIENCES
01.2021 - 07.2021
IPV CASE MANAGEMENT SPECIALIST
JOHNSON AND JOHNSON FAMILY GROUP OF COMPANY
04.2019 - 10.2020
PATIENT SAFETY SPECIALIST ON BEHALF OF ALCON, UK & IRELAND
NOVARTIS PATIENT SAFETY
07.2018 - 04.2019
PHARMACOVIGILANCE OFFICER
HEALTHCARE AT HOME
10.2017 - 05.2018
DRUG SAFETY EXECUTIVE
CROWN PHARMACOVILANCE LTD
03.2016 - 07.2017
Pharma Operations Officer / Adverse Events Lead
ALCURA HEALTHCARE LTD
09.2013 - 03.2016
Dip clinical pharmacy practice - undefined
Robert Gordon University
Dip - undefined
London Training College
B.Pharm - undefined
University of Benin
INTERNAL AUDIT CERTIFIED(ISO 9001:2015)- FEB 2019 -
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