Data Entry Specialist - Risk Management Operations

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Data Entry Specialist - Risk Management Operations

Stockley Park, Hillingdon

Initial 3 months

£TBC

Reporting to the Associate Manager, Risk Management Operations

This role entails support of the routine daily processing high-quality processing of Prescription Authorisation Forms received by our pharma client in accordance with the regulatory mandated risk minimisation program and relevant risk management standards in the UK and Ireland.

This role is responsible for contributing to customer support for the eRMP system ensuring strong external user compliance and consistently excellent customer experience whilst ensuring our clientour client maintains strict adherence to all applicable requirements ensuring continuous audit and inspection readiness.

Skills and Knowledge Requirements:

* Relevant medical / life sciences degree.

* Suitable for a Graduate (Some industry experience preferential but not essential)

* Experience within a Drug Safety team within a pharmaceutical company and understanding of good Risk Management and Drug Safety practices desirable but not essential.

* Operations and customer service experience desirable, but not essential.

* Good process mindset and process development/documentation skills.

* Good understanding of database systems and related IT terminology.

* Some knowledge of medical terminology.

* High level of accuracy and attention to detail with demonstrated efficiency and organisational skills.

* Excellent communication skills, with a strong fluency in written and spoken English.

* Adaptable and able to deal with pressurised environment

* Enthusiastic, self-motivated and able to take the initiative

* Good computer skills; good knowledge of Word and Outlook is essential; experience with working with Excel

* Good presentation skills; comfortable presenting 1:1 and to groups

* Ability to manage external suppliers

Role and Responsibilities

* Responsible for eRMP Data Processing Activities

* Responsible for processing PAFs including entry onto the eRMP System

* Operationalization of Paper PAF Data Entry and Management for UK Risk Minimisation Programmes

* High Quality Data Processing & Quality Assurance of PAF to facilitate oversight of Pregnancy Exposure Prevention Program for Imids as per applicable agreement with the MHRA

* To ensure process conformity with defined standards through generation and review of data entry conventions and metrics

* To contribute to excellence in regulatory compliance through effective PAF workflow management and oversight on all PAFs received by our client at any time

* Support administration and maintenance of UK & Ireland eRMP system and all related processes

* Responsible for meet defined productivity metrics for quality and productivity KPIs

* Responsible for adherence to all relevant WPs/SOPs for all aspects of the role

* Support Data Extraction of eRMP external Customers for reconciliation of PAF data

* Support internal process audit program in collaboration with GDSRM and the Global Compliance Group to monitor compliance with internal and external standards

* Inspection and Audit support i.e. Demo of Data Entry in eRMP Systems as required

* Support Defect/limitation detection and escalation to UK/IE Quality and Compliance Function and GDSRM stakeholders and support close out of CAPA as required