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Scientific Officer-Pharmacovigilance

Reference:A006132
Location: Dublin
Qualification:Degree
Experience:2-3 Years
Job Type:Part-Time
Salary:Not Disclosed
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May be suitable for: Pharmacovigilance

ROLE SUMMARY
Reporting to the Pharmacovigilance Surveillance Assessor, the Scientific Officer (Job share) post is located within the Human Products Monitoring (HPM) department working in the area of evaluation of pharmacovigilance data and contributing to Blood, Tissue & Cell and Organ (BTO) vigilance related activities, as necessary.
The role of the Scientific Officer is to contribute to the safety monitoring of medicines and BTO vigilance activities, to ensure obligations and requirements with regard to reporting are met in an appropriate and timely manner, to appropriately review, evaluate, follow up, collate and present adverse reaction data, to provide input and support for responses to technical and other queries, to support team organisation and activities to achieve required levels of performance and to respond effectively to changes in the internal and external environment.
The Scientific Officer is responsible for contribution to and development of the quality management system for the Pharmacovigilance (PV) section, liaising with the team as necessary. In this regard, the Scientific Officer works closely with colleagues in the PV team and as needed with colleagues, particularly in the wider HPM department.

KEY RESPONSIBILITIES
- StrategicObjectives
o Working closely with the Pharmacovigilance Surveillance Assessor and other members of the team to ensure timely, effective and appropriate processing and evaluation of adverse reaction data, including follow up of individual case safety reports (ICSRs)
o Working with colleagues to facilitate changes to safety reporting requirements arising from revisions to clinical trials legislation
o Contributing to the implementation of system upgrades necessary, through appropriate testing and feedback on system changes and updates to the associated procedures, as appropriate
o Liaising with and providing technical information, advice and guidance on PV matters to HPRA and other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public
o Identifying opportunities for continuous improvement by highlighting quality management issues for review and consideration
o Working with colleagues to ensure that the strategic and operational goals of the PV Section are achieved
o Participating at all levels (Authority, national and international) in the formulation and preparation of regulatory policies, guidelines and procedures
o Attending and contributing to meetings, as necessary

- Operational Objectives
o Supporting the Pharmacovigilance Surveillance Assessor and other team colleagues
o Preparing and compiling PV data for review and drafting reports, including as required:
o Company database searches
o EudraVigilance/WHO database searches
o Literature and other searches, as needed
o Requests for company database searches
o Contributing to the review, evaluation and follow up of individual and cumulative safety data
o Contributing to the review and analysis of adverse reaction reporting trends
o Contributing to the preparation of PV related publications
o Assisting in the implementation and maintenance of quality management in the PV section, including identifying potential problems and providing solutions in a timely manner
o Highlighting any company/sponsor compliance concerns with PV obligations and liaising with team colleagues, particularly the Pharmacovigilance Compliance group to ensure follow up to address any issues identified
o In the absence of more senior technical staff, reviewing incoming PV data to identify any urgent/emerging safety issues requiring immediate action and liaising with colleagues to progress these, as necessary

- Technical Objectives
o Database/IT
o Pharmacovigilance Compliance
o Quality Control

QUALIFICATIONS AND EXPERIENCE
- The ideal candidate will have:
o 3rd level degree in a relevant scientific or related discipline
o A minimum of 2 years experience with pharmacovigilance and adverse reaction
reporting/monitoring activities
o Previous experience with electronic reporting systems, clinical data management or
clinical research would also be an advantage
o Knowledge of relevant European and National legislation, guidelines and reporting
requirements
o Excellent communication skills with the proven ability to deliver appropriate information
to the right people using a range or written, verbal and presentation skills
o Excellent data analysis skills
o Demonstrated initiative and problem-solving capabilities
o Proven ability to work effectively as part of a multi-disciplinary team
o Proven ability to work unsupervised
o Highly motivated and with the ability to manage deadlines


If you would like further Information you can contact the recruiter directly:

Libby Ryan | Tel: +353 (0) 1 507 9254




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