EMEA/AD/258: Head of Sector Pharmacovigilance and Risk Management of Medicinal Products for Human Use (AD9).

Transcription

1 EMEA/AD/258: Head of Sector Pharmacovigilance and Risk Management of Medicinal Products for Human Use (AD9). Responsible, under the Head of Unit for the Post-Authorisation Evaluation of Medicinal Products for Human Use, for management of the Sector Pharmacovigilance and Risk Management: All pharmacovigilance activities at the level of the Agency relating to centrally authorised products for human use, in particular - the EudraVigilance Database and analysis system - signal detection, risk assessment and benefit:risk evaluation throughout the product life-cycle - support to the Committee for Medicinal Products for Human Use (CHMP), other EMEA Scientific Committees, Working Parties, Scientific Advisory Groups, ad hoc expert groups and expert working groups - risk management including communication to the stakeholders (patients, healthcare professionals, pharmaceutical industry and the general public) - crisis management in pharmacovigilance - input to the European Risk Management Strategy and the EMEA Road Map as regards pharmacovigilance and risk management - implementation and further development of the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance (ENCePP) Overall responsibility for the Sector activities, including management of the Sector Staff Collaboration with other Units and Sectors, e.g. the Pre-Authorisation Human Unit regarding risk management, and the Inspections Sector regarding product defects, pharmacovigilance inspections and Good Clinical Practice (GCP) The incumbent will ensure that the objectives and performance measures in relation to the Sector as laid down in the EMEA Work Programme are adhered to, and that cross Unit and cross Sector activities are coordinated Successful candidates are likely to have: Clinical experience and extensive knowledge in the field of pharmacovigilance, including signal detection, and risk management Management skills and managerial experience, including capacity for managing and motivating staff with particular emphasis on the promotion of teamwork, maximisation of efficiency and experience in chairing meetings Good knowledge of pharmacoepidemiology Good knowledge of European pharmaceutical legislation Experience in project management and quality systems implementation/operations Experience in planning and reporting activities Experience in the use of information and communication technologies Diplomatic skills, allowing appropriate liaison with the services of the Community Institutions and with the National Competent Authorities Ability to communicate and present the Agency s position externally and to staff internally Experience in working in a multicultural environment. Essential requirements for this post: 1. A university degree in the field of medicine, pharmacy or other relevant life sciences 2. At least 12 years professional experience after obtaining the relevant degree, that must have been obtained by the closing date, of which at least three years should be relevant to the description of duties outlined above 3. A good command of English and a thorough knowledge of another language of the Communities to the extent necessary for the performance of duties (for any promotion in the future, knowledge of a third language of the Community would be required) For essential requirements 1. and 2. above candidates will be required to provide proof of each

2 EMEA/AD/259: Administrator, Regulatory Affairs and Organisational Support Unit for the Post-Authorisation Evaluation of Medicines for Human Use, (AD 6) With responsibility, under the Head of Sector for Regulatory Affairs and Organisational Support for: Provision of regulatory and procedural advice in relation to the development, evaluation and surveillance of medicinal products for human use, submitted through the Centralised Procedure from early pre-submission to post-authorisation follow up. Provision of regulatory and procedural advice in relation to referrals for Non-Centrally Authorised Products. Provision of regulatory support to the Committee for Medicinal Products for Human Use (CHMP) and its associated Working Parties and expert Groups, the Committee for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO) Responsible for ensuring co-ordination in the application and interpretation of legislation to the operations of the EMEA in co-operation with other regulatory affairs/legal colleagues and where necessary the European Commission. Provision of regulatory and procedural guidance in compliance with community legislation to Agency staff, all the Human Scientific Committees and their working parties. Responsible for the development of regulatory and procedural guidance through internal and external Standard Operating Procedures, Guidance documents, etc. Provision of regulatory advice in relation to the new pharmaceutical legislation and development of EMEA policy in emerging topics of interest e.g. borderline products, advanced therapies, pharmacovigilance. Successful candidates are likely to have the following qualifications and background experience in the following areas: Extensive Regulatory Affairs experience in a regulatory agency or in Industry In-depth understanding of Community Legislation in the field of pharmaceuticals Experience of interaction with Industry/Regulatory Authorities Experience in working in a team environment. Excellent written and oral communication skills Experience and knowledge in some of the following areas would be an advantage: Biological and biotech medicinal products, advanced therapies Labelling and product information Multi-disciplinary project management & technical meeting support Experience in working in a multicultural environment Essential requirements for this post are: 1. A university degree in pharmacy, medicine or life sciences 2. At least three years professional experience after obtaining the relevant degree, that must have been obtained by the closing date, relating to the field covered by the above description of duties 3. A good command of English and a thorough knowledge of another language of the Communities to the extent necessary for the performance of duties (for any promotion in the future knowledge of a third language of the Community would be required) For essential requirements 1. and 2. candidates will be required to provide proof of each one prior to the interview stage. 2/8

3 EMEA/AD/260: Administrator in the Medical Information Sector, Unit for the Post- Authorisation Evaluation of Medicines for Human Use (AD 6) With responsibility, under the Head of Sector for Medical Information, for Writing medical information in plain language particularly the European Public Assessment Report (EPAR) summaries; Providing support to other Sectors/Units with regard to the preparation of medical information intended to health care professionals, patients or the general public for publication on the EMEA website such as question-and-answer documents (mainly in Pharmacovigilance field); Provide support on other written documents especially press releases and lines to take and other documents in relation to medical information especially in the area of medicines for children; Contribute to the improvement of the EMEA website with regard to provision of information to the public; Contributing, implementing and adhering to quality assurance system of the EMEA including preparation of guidelines Standard Operational Procedure (SOP) and templates. The successful candidates are likely to have experience and skills in the following areas: Excellent communication/language skills; Good understanding of medicines, pharmaceuticals and the information needs of patients and the general public; Ability to communicate clearly while keeping strictly to the rules; Ability to work effectively within given timeframe; Ability to translate complex information into the right language for the audience, i.e., healthcare professionals, patients or the general public. Experience and knowledge in one or more of the following areas would be an advantage: Understanding of Community legislation in the field of Pharmaceuticals; Working in a team environment; At least three years experience in medical writing Essential requirements for this post: 1. A university degree preferably in the field of life sciences, medicine, pharmacy or languages (e.g. linguistics) 2. At least three years professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the fields covered by the above description of duties 3. An excellent command of English and a thorough knowledge of at least one other official Community language (for any promotion in the future, knowledge of a third language of the Community would be required) For essential requirements 1. and 2. candidates will be required to provide proof of each one prior to the interview stage. EMEA/AD/261: Administrator (Scientific), EudraVigilance, Unit for the Post-Authorisation Evaluation of Medicines for Human Use (AD6) With responsibility, under the Head of Sector for Pharmacovigilance and Post-Authorisation Safety and Efficacy of Medicines, for Performing customised scientific and administrative database queries and statistics on request of EMEA s Scientific Committees and Working Parties using SAS, Microstrategy and Oracle 3/8

4 Developing business requirements for pharmacovigilance informatics projects Developing customised scientific and administrative database queries and statistics using SAS, Microstrategy and Oracle in order to integrate additional scientific data sets (e.g. THIN) within EudraVigilance Development of statistical methods in relation to the analysis and evaluation of adverse drug reaction data Management of medicinal product information for data analysis Supporting the use of standard terminologies (e.g. MedDRA, MedDRA SMQs, EVMPD) for data analysis and signal detection Preparation of training material and support of training courses for regulators and pharmaceutical industry Preparation of use cases, storyboards, SOPs, WINs and guidelines Liaison with pharmaceutical industry, sponsors of clinical trials and national Competent Authorities regarding all aspects of signal detection and evaluation of pharmacovigilance data Supporting all activities related to the electronic transmission and management of individual case safety reports (ICSRs) in the frame of the EudraVigilance project Duplicate detection and administration in EudraVigilance Recoding administration in EudraVigilance Successful candidates are likely to have: High competence in IT and/or statistics preferably in the area of pharmacovigilance and/or pharmaceuticals Knowledge of the use of statistical software Experience in the use of databases Experience in working in a team environment Good oral and written communication skills Experience and/or sound knowledge in several of the following areas would be an advantage: SAS (including the IML module), Microstrategy and/or Oracle Other statistical software packages MS Access SQL and PL/SQL Data warehouse and data mining tools Three layers IT architectures: database servers(oracle), application servers and web servers Reference data models and ontology Statistical and scientific analysis of pharmacovigilance data Active involvement in implementing a database Pharmacovigilance database use MedDRA Basic understanding of epidemiology ICH E2B(R2)/M2 standards Signal detection in pharmacovigilance or the pharmaceutical/clinical domain Experience in working in a multicultural environment Community procedures related to the various aspects of pharmacovigilance and/or pharmaceuticals Essential requirements for this post are: 1. A university degree in one of the following subjects: statistics, informatics, IT, physics, mathematics, pharmacy, chemistry, pharmaceutical technology or medicine 2. At least three years professional experience, after obtaining the relevant degree in the field, that must have been obtained by the closing date 3. A good command of English and a thorough knowledge of another language of the Communities (for any promotion in the future a third language of the Community would be required) 4/8

5 For essential requirements 1. and 2. candidates will be required to provide proof of each one prior to the interview stage. EMEA/AD/262: Administrator (Scientific), EudraVigilance, Unit for the Post-Authorisation Evaluation of Medicines for Human Use (AD5) With responsibility, under the Head of Sector for Pharmacovigilance and Post-Authorisation Safety and Efficacy of Medicines, for Dealing with requests to access to pharmacovigilance/eudravigilance data Supporting of all pharmacovigilance activities related to the EudraVigilance project Duplicate detection and administration related Individual Case Safety Reports (ICSRs) reported to EudraVigilance Management of medicinal product information in the EudraVigilance Medicinal Product Dictionary (EVMPD) Performance of standardised queries and statistics on request of stakeholders using the EudraVigilance Data Warehouse and Analysis System (EVDAS) Support of signal detection and analysis in EudraVigilance Interaction with stakeholders related to questions in the area of EudraVigilance and pharmacovigilance Writing of guidelines, standard operating procedures, work instructions and training material in relation to EudraVigilance and pharmacovigilance Successful candidates are likely to have: Knowledge of EU pharmacovigilance guidelines and pharmaceutical legislation Knowledge in the area of clinical trials and epidemiology Excellent written and oral communication skills Knowledge in several of the following areas would be an advantage: Professional experience relevant to the description of duties outlined above Signal detection and data analysis in pharmacovigilance Conduct and reporting of epidemiological studies Statistical software packages Information Technology, preferably in the use of a pharmacovigilance or medicinal product database Medicinal product and substance classification and terminologies Essential requirements for this post are: 1. A university degree in pharmacy, chemistry, pharmaceutical technology, medicine, life science, statistics, informatics or IT 2. A good command of English and a thorough knowledge of another language of the Communities to the extent necessary for the performance of duties (for any promotion in the future knowledge of a third language of the Community would be required) For essential requirements 1. and 2. above candidates will be required to provide proof of each EMEA/AST/263: Assistant, Regulatory Affairs and Organisational Support, Unit for the Post- Authorisation Evaluation of Medicines for Human Use, (AST 3) Reporting to the Section Coordinator of the Central Information Group (CIG), providing a support service to both pre and post authorisation Human Units as well as to the Administration Unit working in close collaboration with a number of secretarial and archiving colleagues within the CIG. The specific responsibilities of the position would include the following: 5/8

6 - Primary responsibility for document management concerning all phases in the processing of centralised applications from pre-submission to post authorisation activities. In particular these activities include: - Co-ordinating work within the CIG to ensure systematic preparation of product Master Files in accordance with written procedures and the development of such procedures. - Supervising mail managers to ensure an efficient distribution of all documents received to the relevant contact points within the sectors and to external partners e.g. Marketing Authorisation Holders (MAH), European Commission and National Competent Authorities. - Handling of electronically application documentation (e-ctd) and the development of related procedures and written documentation. - Participation on an as needed basis in pre-submission meetings with future applicants, Marketing Authorisation Holders (MAH) and (Co)-rapporteurs in support of new and post authorisation procedures. - In capacity as financial clerk handling all fee related activities associated with centralised applications in accordance with EMEA Rules of Procedure and Financial Regulations ensuring SI2 (financial database) entries are made to a consistently high level of accuracy. - Liaison with other colleagues in preparation of budget documents concerning the Human Units including the monitoring of expenditure on meetings. - Participation in budgetary planning meetings with Administration and both Human Units. Other responsibilities would include: - Coordinating the Unit s statistics in relation to monthly and 6 monthly sector plans, annual reports and work programme and monthly statistics on fee income - Supporting the work of the SIAMED Administrators to ensure updating of the tracking system with accurate information on ongoing applications - In conjunction with Product Team Leaders co-ordination of the validation of applications received - Preparation of timetables, line listings and other documents in support of Committee for Human Medicinal Products (CHMP ) meetings. - Preparation of letters, faxes, s and transmission of CHMP opinions/assessment reports to applicants, MAHs (Co)-rapporteurs and the European Commission - Provision of ad-hoc support to delegates of CHMP as required - Responsible for supervision of mail managers and document. Successful candidates are likely to have experience and skills in the following areas: - Meticulous approach with excellent organisational ability - Capacity to take initiative with a mature assertive attitude - Strong sense of personal responsibility - Working in a team environment - Good oral and written communication skills. - Experience in working in a Regulatory affairs environment Experience and knowledge in the following areas would be an advantage: - Experience of working in a multicultural environment - Experience of working with electronic document management tools - Experience of working with financial processes Essential requirement for this post are: 1. Post-secondary education diploma, plus six years professional experience or 2. A secondary education certificate giving access to post-secondary education plus three years professional experience (which is the equivalent of the educational requirement in the first indent), plus a further six years experience making a total of nine years professional experience 6/8

7 3. Three years of the professional experience required must be in the fields covered by the above description of duties 4. A good command of English and a thorough knowledge of another language of the Communities (for any promotion in the future a third language of the Community would be required) For essential requirements 1. or 2. and 3. candidates will be required to provide proof of each EMEA/AD/264: Administrator (scientific) Unit for the Pre-Authorisation Evaluation of Medicines for Human Use, Quality of Medicines (AD5) Under the Head of Unit/Head of Sector in the Human Medicine Units Sector Quality of Medicine, in particular for: Providing scientific, technical and administrative support for the assessment of products and other scientific or regulatory projects involving the Agency s committees and groups of experts, managing the procedures of the Centralised Procedure of marketing authorisation and amendments, contributing to the scientific secretariat of Working Parties e.g. Biologics, Blood Products, Vaccines, Cell Therapies. Managing the procedures concerning centralised files and amendments (e.g. variations) thereto, providing scientific, technical and administrative support for projects involving the Agency s committees and groups of experts, liaising with rapporteurs/co-ordinators and coordinating the activities essential to the establishment of objective scientific opinions on medicinal products for human use. Successful candidates are likely to have scientific training in pharmacy or other life sciences with relevance to project management in the above-described activities and to have experience in working in a multicultural environment. Specific training and experience in fields such as biotechnologies, emerging technologies associated with advanced therapies (e.g. cells, gene therapy, tissue engineering and medical devices used in such products, nanotechnologies) would be an advantage. General knowledge in the field of development pharmaceutics, formulations and generic medicinal products including bioequivalence would also be an advantage. Professional experience in the fields mentioned above of three years or more would be an advantage. In addition, general knowledge of Community institutions including the Agency and the pharmaceutical legal framework is expected. Essential requirements for this post: 1. A university degree relevant to the field of pharmacy or other relevant life science 2. A good command of English and a thorough knowledge of another language of the Communities to the extent necessary for the performance of duties (for any promotion in the future knowledge of a third language of the Community would be required) For essential requirements 1. and 2. above candidates will be required to provide proof of each EMEA/AD/265: Administrator, Filemaker developer (AD6) With responsibility, under the Head of Sector for IT, for the: Design, definition, implementation and maintenance of Filemaker databases (currently versions 8.5 and 9, to be migrated to newer versions as released). 7/8

8 Standards for the setting-up and use of the Filemaker development, test and production environments Monitoring, tuning and optimising the Filemaker databases. Successful candidates are likely to have background and experience in the following areas: At least three years of experience of developing in Filemaker, including experience on the latest version 9.x. Full life cycle development experience: Gathering user requirements; Developing prototypes; writing, maintaining and testing programs; Deploying applications; Producing technical documentation; Assisting in user training and support; The candidate will be expected to work independently, to liaise effectively with teams and to have overall good interpersonal skills; Experience of working in a multicultural environment. Experience and background in the following areas would be an advantage: Knowledge of SQL and experience with connecting Filemaker databases to Oracle Supervisory experience Knowledge of XML and Adobe Intelligent Forms Essential requirements for this post: 1. A university degree in the field of IT, Sciences or Engineering 2. At least three years professional experience, after obtaining the relevant degree that must have been obtained by the closing date, in the fields covered by the above description of duties 3. A good command of English and a thorough knowledge of another language of the Communities to the extent necessary for the performance of duties (for any promotion in the future knowledge of a third language of the Community would be required) For essential requirements 1. and 2. above candidates will be required to provide proof of each 8/8