Name of employee: Revised: Title: Department name: (e.g. Patient Solutions Thrombosis) Org. Unit ID (optional): (e.g ) Location: Job type:

Transcription

1 1. JOB DESCRIPTION Please fill in this form and save it as described in SOP_ Background information Name of employee: (John Doe) LEO-id: (AAAUS) Revised: (date and version) Title: (E.g. Specialist, coordinator, project manager Head of Department etc.) Department name: May 2018 Version 2 Pharmacovigilance Associate Pharmacovigilance & Medical Information (e.g. Patient Solutions Thrombosis) Org. Unit ID (optional): (e.g ) Location: (Country/State/Provence/Region or City) United Kingdom Job type: (e.g. Business Administration & Support, see Pulse for more info, here) Job Level: (e.g. P3, see Pulse for more info, here) Immediate manager title: (Reports to e.g. Vice President Sourcing) P2 PV & MI Manager Business responsibility (if applicable) No. of direct reports: 0 Financial magnitude: (Budget owner, P/L, Sales and/or Cost) Authority: (Areas where the position holder is accountable) None Pharmacovigilance UK/IE, Scientific Affairs Objectives and tasks Overall objective: (Short description of the overall objective of the position - the purpose of the role) 1. To provide assistance and support to the SCP and dscp with the day to day running of the UK/IE pharmacovigilance functions within LEO Pharma. 2. Activities will include ICSR processing including QC and data entry into SIMBA, reconciliation, training, literature review and tracking. Version 4.0 last edited December 2016

2 2/5 3. To provide assistance and support to the Senior Quality manager with the day to day running of the UK/IE Quality Complaints processing within LEO Pharma. 4. Undertake tasks under direction of the SCP dscp related to the PV review of the Medical information Outsourcing partner including QC, reconciliation 5. Undertake Medical information tasks related to medical information escalations and QC of medical information calls 6. Organisation of off-site archiving of PV case files Role and responsibilities: (Short description of the tasks and responsibilities which are key to the role. List in prioritised order) 1. ICSR Case Management Ensure ICSR case management compliance tasks to be undertaken include but are not limited to limited to monitoring of the UK/IE drug safety in box, triage of cases, data entry to SIMBA, QC of data entry forwarding of ICSRs to GPV, QC of CIOMS, case closure in accordance with local and global deadlines. Assist the SCP and dscp with day to day monitoring and administrative tasks concerning the Medical Information Outsourcing Partner including QC and report production. Assist in all training tasks to ensure PV training is compliant and up to date for all LEO personnel and third parties. 2. Reconciliation To work closely with the SCP/dSCP to ensure compliance and reconciliation is completed within timelines. This includes, but is not exclusive to: Monthly line listings from Medical Information Product Complaints Reporting to ethics committees and investigators Patient Support Programmes and Market Research Projects 3. Training To arrange, track, record, arrange certificates (as appropriate) and when relevant, develop and deliver Pharmacovigilance training for all LEO UK/IE personnel

3 and third parties to include 3/5 Medical Information Support and assist the PV & MI Manager in the escalation of MI enquiries and responses in a timely manner Support the process of QC of medical information enquiries in line with procedure.. 4. Complaints Support and assist the Senior Quality Manager in the maintenance of the Product Quality Complaints system. Complete and maintain tracking sheet in line with procedure. Liaise with and respond to customers, authorities, and LEO functions as appropriate. 5. Journal and literature maintenance Assist in ensuring Journal subscriptions are maintained and PV review of Journal in undertaken within timeframes and all appropriate documentation is completed correctly. Complete and maintain tracking sheet in line with Department procedures 6. Archiving Assist in the Oversight and Maintenance of archiving system for Pharmacovigilance including Collaboration with outsourced archive company Assist in Oversight and maintenance of a record of all information held off site at the are archive company 7. Audits To participate in audits and inspections. Ensure audit findings CAPAS and deviation are actions and evaluated in accordance with procedures. 8. General To participate in meetings within LEO Pharma, contribute to discussions, present information and generate documentation as required, with the

4 4/5 aim of achieving drug safety processes of the highest professional standard Any other duties as required by MI/PV Manager Medical Information Keep up to date with changes and developments in PV legislation/ regulations and guidelines and LEO internal processes Key working relationships: (Interface and cooperation with e.g. internal functions or external partners) External: Medical Information, Contractors, Healthcare Professionals, Consumers, Customers, the approprate authorities, Clinical Trial Investigators, Market Research Organisations, Patient support programmes. Companies from whom LEO have acquired products Global Pharmacovigilance; LEO UK and other LEO affiliates Internal: Global Pharmacovigilance; LEO UK and other LEO affiliates Other departments and staff at the affiliate and cluster level, other cluster regional offices, GPV and other SCPs/dSCPs as needed or required. Job specific competencies Requirements to e.g.: professional competencies (education, training, experiences) Life science degree or qualified Pharmacist 1 year experience in pharmacovigilance preferable but not mandatory Good oral and written communication Good IT skills Working knowledge or awareness of Pharmacovigilance legislation Self motivated and organised business insights (knowledge of the business and industry) behavioural competencies (demonstrated behaviours - see Pulse Communication Skills Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences

5 for more info, here) Drives Results Consistently achieving results, even under tough circumstances 5/5 Job description hereby understood and agreed: Date: The correctness of the job description is hereby confirmed : Date: Employee s signature Manager s signature Acknowledgement LEO Pharma reserves the right to make modifications to this job description as deemed necessary by changing position and business requirements. The job description is a requirement under LEO Pharma's Quality Management System. It does not form part of the employment agreement between the employee and LEO Pharma and cannot be relied on in this respect.