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Data Entry Specialist, Risk Management Operations

  • Salary: £80 - £136 per day
  • Job type: Contract
  • Location: Uxbridge, Middlesex
  • Sector: Database Admin
  • Date posted: 20/07/2018
  • Job reference: DESC0001

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Data Entry Specialist, Risk Management Operations x 3

Stockley Park, Uxbridge

Contract Length: 6 Months (13/8/2018 - 12/2/2019)

£17 per hour


Reporting to the Associate Manager, Risk Management Operations, this role is responsible for the routine daily processing high-quality processing of Prescription Authorisation Forms received by Celgene UK & IE in accordance with the regulatory mandated risk minimisation program and relevant risk management standards in the UK and Ireland.

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

Role and Responsibilities include but are not limited to the following:

Responsible for eRMP Data Processing Activities

  1. Responsible for processing PAFs including entry onto the eRMP System
  2. Operationalisation of Paper PAF Data Entry and Management for UK Risk Minimisation Programmes
  3. 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
  4. To ensure process conformity with defined standards through generation and review of data entry conventions and metrics
  5. To contribute to excellence in regulatory compliance through effective PAF workflow management and oversight on all PAFs received by Celgene UK & Ireland at any time
  6. Support administration and maintenance of UK & Ireland eRMP system and all related processes
  7. Responsible for meet defined productivity metrics for quality and productivity KPIs
  8. Responsible for adherence to all relevant WPs/SOPs for all aspects of the role
  9. Support liaison with the Celgene DSRM team to ensure reporting of all Adverse Events and Pregnancy Prevention Programme violations received in relation to the use Celgene products
  10. Ensure Adequate handling and archiving of received Paper PAFs
  11. Conduct follow-up of illegible Paper PAFs i.e., received via fax or illegible/missing information e.g. pharmacist signature with external customers as required
  12. Support Data Extraction from eRMP for Regulatory Audit Reports and Treatment Continuation Scheme
  13. Support Data Extraction of eRMP external Customers for reconciliation of PAF data
  14. As required provide subject matter expertise for eRMP data entry activities and system data entry functionality

eRMP Customer Relationships

  1. Contribute to PAF Processing to generate eRMP data necessary to ensure pharmacies and hospitals maximise their compliance with the UK risk minimisation program
  2. Support excellent first line customer support for all internal and external users of eRMP in UK & Ireland
  3. Support roll-out of eRMP UK to all external users, working with KAMs and other relevant colleagues to identify potential users and implementation opportunities

eRMP Quality Initiatives

  1. Contribute to quality control process for paper PAFs in line with local and global Drug Safety requirements
  2. Support RMO team in reaching the targeted KPIs Support assessment and rollout of eRMP system in accordance with global drug safety strategy
  3. Support alignment of local and global eRMP platforms
  4. Inspection Readiness
  5. Support internal process audit program in collaboration with GDSRM and the Global Compliance Group to monitor compliance with internal and external standards
  6. Inspection and Audit support i.e. Demo of Data Entry in eRMP Systems as required
  7. Support Defect/limitation detection and escalation to UK/IE Quality and Compliance Function and GDSRM stakeholders and support close out of CAPA as required

Outputs include:

  • Productive and efficient RM Operations data entry
  • Due Dilligence Follow-up with hospitals
  • Reports to support RMO Quality Assurance Processes
  • PAF Data Entry Corrections
  • Corrective and Preventative Actions as required

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
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