Arriello Career 2019 4

Current opportunities at Arriello.

Here's how to join #TeamYellow


and do it...
faster, better, smarter.

Quality Specialist.

We're looking for experienced Quality professionals, speak to us now!

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Before applying for a position, watch this video.

Zuzana Durňaková, Arriello's Talent Acquisition Manager, talks about our unique culture and how every employee plays an important part in our growing business. It also helps you understand our recruitment process and if you are likely to be the right fit at Arriello.

And if you are the right fit, this video will also encourage you to apply and hopefully become a part of the growth of #TeamYellow.

 

"Arriello is a multi-cultural, friendly and open-minded place where people can learn, share their views and grow in every way. We are constantly trying to challenge the status-quo and bring the highest-quality service to our clients to meet our faster, better, smarter promise."

Zuzana Durňaková about Arriello's unique culture

Zuzana Durňaková
Talent Acquisition Manager

Our job positions.

Have a look on our open positions below.

 

Lead Developer

  • Act as a bridge between the Marketing team and Commercial team;
  • Proactively review Marketing team generated leads list to evaluate the quality of the data
  • Use various communication channels in leads qualification process: phone calls, LinkedIn connections, LinkedIn Sales Navigator, voicemails, conversations, teleconferences , emails etc;
  • Ensure the Arriello company and services are presented in the brief by reflecting our capabilities;
  • Ensure that the initial screening/qualification is performed, and qualified prospect/lead need is identified before passing it to Commercial team for further communication;
  • Able to describe Arriello capabilities and key competitive advantage in brief in Pharmacovigilance, Regulatory Affairs and Clinical Safety fields;
  • Keep strong communication path with leads which are under qualification;
  • Keep CRM and other relevant systems up to date;
  • Ensure that lead status is reflected in CRM and required fields are completed;
  • Track successful leads conversion into Opportunities ratio and report to Line Manager;
  • Ensure that qualified lead is described by basic criteria at least: who they are, what they do, what is the pipeline and potential area for Arriello support/services;
  • Qualified leads shall be passed to Commercial Operations Director for further assignment based on Commercial team setup and availability;
  • Qualified lead from Arriello existing Clients shall be passed directly to Account Manager or another responsible person as defined in CRM;
  • Participate in weekly Commercial team meetings and contribute to continuous improvement processes based on Clients expectations or/and lessons learnt;
  • Provide the reports on the activities and conversion rate to Line Manager;
  • Work with the Commercial team to evaluate unsuccessfully qualified needs;
  • Contribute to the execution of Commercial team financial goals and objectives;
  • Support with Account Management responsible personnel when necessary;
  • Develop and maintain a well-coordinated internal relationship with key decision-makers within the organisation;
  • Ensure that IT solutions are described to Prospects/Leads in brief (e.g. Veeva and IntelliCASE) and unique selling points are defined;
  • Implement changes to support Arriello development based on industry and your personal best practices.

Apply for this position

Pharmacovigilance Associate

  • Executes project tasks primarily specific to the unit, but also cross-functional, including without limitation Global ICSR processing, Global Literature monitoring, Signal Management and Benefit Risk Management activities, Medicinal Product Management ( XEVMPD), Local project management (Local literature monitoring management, Local ICSR management, LPPV/LSO management, Monthly reporting and compliance monitoring), Regulatory Intelligence, preparation and QC of pre-marketing and post-marketing aggregate reports (e.g. PSUR, DSUR, PBRER, PADER, etc.) Risk Management Plans (RMP), Study protocols (interventional and non-interventional studies), product documentation (SmPC, IB), Pharmacovigilance system master file (PSMF), Management of project related PV contracts (PV service agreements, Safety data exchange agreements), Pharmacovigilance system master file management,
  • Participate in meetings with project members as required;
  • Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place;
  • Follow and achieve agreed personal KPIs and KPIs of the department
  • Provide training to project team members and other PV department employees on technical areas as needed
  • Participate on trainings, both internal and external as required
  • Improve teamwork collaboration by sharing best practices
  • Constantly seek for and take into consideration the client and internal feedback to improve the efficiency and quality of work within the assigned projects
  • Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication, ensuring full compliance with the processes and project deliverables
  • Ensure that all CAPAs related to assigned projects and tasks are managed within the timelines;
  • Work cross-functionally and in collaboration with key stakeholders/customers, both internal (e.g., Commercial, Technical, Quality, Regulatory, Pharmacovigilance, etc.) and external (e.g., Competent Authorities, Clients, External Vendors, etc.)
  • Participate in business meetings, bid defences with current and potential clients, as and if required
  • Participate in audits and inspections, as and if required
  • Participate in company marketing and promotional activities, as and if required
  • Organise and file the document according to the company’s document management system
  • Use company’s databases, systems and any other IT tools applicable for the job in line with company procedures
  • Adhere to company’s processes and systems

Apply for this position

Pharmacovigilance Intern - Safety Data Management Unit

  • Assistance with PV related tasks
  • Administrative work at the department – may include, but is not limited to:
  • Editing, scanning, printing, and filing/archiving of the documents according to good documentation practice and Arriello quality system;
  • Revision, formatting, editing of functional project documents – templates, tables, reports, manuals, and plans;
  • Technical support of PV Department in pharmacovigilance-oriented tasks, e.g., Global Literature Monitoring – reviewing medical journals for the presence of safety information, Case Processing
  • Adherence to the company’s processes and systems
  • Organize and maintain project files and keep databases updated
  • Education in Pharmacovigilance processes

Apply for this position

Data Analyst

KEY RESPONSIBILITIES:

  • Working alongside various teams or top management to establish reporting needs.
  • Assist various departments in getting recurrent and ad hoc reports, or design dashboards.
  • Collect and interpret data, analyse results and reports the results back to the relevant members of the business.
  • Identifying patterns and trends in data sets.
  • Correlate various metrics and trends to identify opportunities / waste.
  • Compile data from different sources of the same type (e.g. time tracker, profitability)
  • Identify root cause of data quality issues and fix it alone or together with other colleagues / external partners.
  • Supports Arriello during internal and external audits with reports, logs and other data base evidence

As part of a current company's strategic project to implement a new ERP:
  • Design the SQL DB structure
  • Design and Improve data entry points to ensure input data quality and standardisation
  • data Standardisation and Normalisation of historical data.
  • Document in depth the current information flows
  • Design the optimal information flow and architecture (how data from different systems is integrated)

Apply for this position

Pharmacovigilance IT Systems Specialist

  • Executes project tasks and activities related to the Company PV IT systems
  • Works in close cooperation with the PV IT Systems Manager for further tasks allocation
  • Collaborate with technology teams and business users to manage implementation, training options and support
  • Review of existing systems by applications demos and meeting IT personnel
  • Coordinates the usage of PV IT system and act as administrator of those systems
  • Internal support to PV team with the PV information system
  • Provides architectural and technical inputs to the project
  • Analyse potential solutions to ensure obtain future needs
  • Create and review technology RFPs
  • Coordinate with partners to define scope and act as a point of contact for the agreed partners
  • Plan and implement effective testing processes to ensure that deliverables adhere to standards.

KEY RESPONSIBILITIES:
  • Coordinates the implementation and maintenance of the PV safety database
  • Coordinates the communication with the PV safety database provider
  • Act as a system co-owner for the PV IT systems
  • Work on projects and tasks related to the PV IT systems
  • Facilitate meetings with project members as required
  • Follow and achieve agreed personal KPIs and goals
  • Provide training to project team members and other PV department employees on technical areas as needed
  • Participate on trainings, both internal and external as required
  • Improve teamwork collaboration by sharing best practices
  • Constantly seek for and take into consideration the client and internal feedback to improve the efficiency and quality of work within the assigned projects
  • Properly escalate to management all unresolved issues or identified improvements proposed for implementation;

Apply for this position

PV Assistant

  • Assistance with PV tasks
  • Administrative work at department – may include, but is not limited to:
o Editing, scanning, printing and filing/archiving of the documents according to good documentation practice and Arriello quality system;
o Revision, formatting, editing of functional project documents – templates, tables, reports, manuals and plans;
o Project specification agreements/PV manuals or another PV documents preparation according to the template as needed
o Supporting reports and questionnaires compilation;
o Support with trainings (training records, filing, etc.)
o PV department tracking;
  • Administrative support in communication with internal and external vendors
  • Support of PV Specialists in running projects or processes
  • Adherence to company’s processes and systems
  • Support in projects compliance monitoring (collecting data, preparation of reports)
  • Organize and maintain project files and keep databases updated

Apply for this position

Local PV Intern

  • Supporting Local PV Team in managing daily administrative tasks
  • Compiling and Maintaining local medical literature data and records updated as per instructions from senior personnel
  • Having oversight of the Local Medical literature in countries all over the world
  • Proactively seeking new information regarding the medicinal literature on websites
  • Communicating with Medical libraries in different countries
  • Help team with assigned documents completion, data upload into systems in timely manner
  • Proactively participate in team meetings, learn new processes
  • Develop ability to understand the processes
  • Improve cooperation skills with team and stakeholders

Apply for this position

Special Projects Lead

KEY RESPONSIBILITIES:

  • Provide support to the CEO/COO in managing their agendas including;
  • The organisation of meetings and the maintenance of confidential files and projects
  • support the CEO/COO in the prioritisation of their workload and responding appropriately and filtering requests on their behalf.
  • Responsible for the administration of CEO/COO meetings.
  • Organise attendances at external conferences, away days and other meetings as required
  • Provide support to the Senior management team, as agreed with the CEO/COO
  • From time to time represent the CEO / COO in meetings both internal and external at various levels including; delegating and decision making on their behalf as agreed, delegation to management team, management and control of special projects internal or external
  • Identify changes needed in the work they are involved in, to help the business adopt best practices
  • Support or manage as needed, projects around new location set up, legal registrations, travel, etc…
  • Support the CEO / COO and your peer group with ideas, knowledge, etc. when the opportunity arises
  • Manage communications coming from the CEO/COO to employees or external partners as needed
  • Prioritise activities across the business to support the CEO/COO
  • Act on behalf of the CEO/COO as agreed, across all levels of the company structure
  • Support the CEO and COO with non-company related activities as agreed
  • Collaboration with Senior Management team to meet the expectations of the CEO/COO

Apply for this position

Business Development Manager

  • Excellence in communication with clients and prospecting
  • Delivering solutions to issues in collaboration with partners and internal stakeholders
  • Effectively manage and build relationships with prospects and lead opportunities from starting point up to deal closure
  • Excellent result delivery in line with company strategy
  • Good market/services understanding in order to reach target clients
  • 2nd Point of Contact with prospects after receiving qualified leads from a Lead Developer
  • The first point of contact for presenting Arriello by phone and face to face
  • Clearly defines and scopes opportunities to ensure that opportunity is in line with company strategy
  • Good financial/profitability understanding
  • Ability to run portfolio and monitor financial field of live opportunities

Apply for this position

Pharmacovigilance Specialist

  • Work on projects and tasks assigned by the unit team lead
  • Organize meetings with project members as required
  • Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place;
  • Follow and achieve agreed personal KPIs and KPIs of the department
  • Act as a process owner for assigned PV processes
  • Provide training to project team members and other PV department employees on technical areas as needed
  • Participate on trainings, both internal and external as required
  • Improve teamwork collaboration by sharing best practices
  • Constantly seek for and take into consideration the client and internal feedback to improve the efficiency and quality of work within the assigned projects
  • Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication, ensuring full compliance with the processes and project deliverables
  • Ensure that all CAPAs related to assigned projects and tasks are managed within the timelines
  • Work cross-functionally and in collaboration with key stakeholders/customers, both internal (e.g., Commercial, Technical, Quality, Regulatory, Pharmacovigilance, etc.) and external (e.g., Competent Authorities, Clients, External Vendors, etc.)
  • Participate in business meetings, bid defences with current and potential clients, as and if required
  • Participate in audits and inspections, as and if required
  • Participate in company marketing and promotional activities, as and if required
  • Organise and file the document according to the company’s document management system
  • Use company’s databases, systems and any other IT tools applicable for the job in line with company procedures
  • Adhere to company’s processes and systems

Apply for this position

EU QPPV

  • Have sufficient authority over the pharmacovigilance system (Arriello PV System or Clients PV system where applicable) in order to promote, maintain and improve compliance. Develop and maintain the Pharmacovigilance System Master Files (PSMFs) ensuring that the PSMFs are accurate and up-to-date reflections of the pharmacovigilance system.
  • Act as a responsible person and administrator for EudraVigilance for Arriello and clients which subcontract pharmacovigilance to Arriello
  • Establish and maintain the system, which ensures that all safety information reported to Arriello/Client on investigational, authorised and marketed medicinal products is collected, evaluated and collated and accessible at least at one point within the EEA.
  • Have awareness of risk minimisation measures (RMMs) and when applicable provide a medical input (through your own knowledge and consults the medically trained designee when applicable) into them.
  • Provide medical input (through your own knowledge and consults the medically trained designee when applicable) into Risk Management Plans (RMP) and have authority over content of the RMP. Act as final signatory for RMPs for products under scope.
  • Provide medical input (through your own knowledge and consults the medically trained designee when applicable) Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR) have authority over content of the PSUR/DSUR. Act as final signatory for PSURs/DSURs for products under scope.
  • Review and approve of protocols of Post Authorisation Safety Studies (PASS) conducted in the EU or pursuant to a RMP agreed to in the EU
  • Act as a single point of PV contact for competent authorities in Member States and the Agency on a 24-hour basis and as contact point for PV inspections
  • Ensure that procedures are in place to assure the required reports are sent to competent authorities of the Member States and the European Medicines Agency (EMA) as well as other Health Authorities (as applicable) within regulatory timelines and relevant monitoring mechanisms are in place. The required reports include:
 Individual Case Safety Reports (ICSR)
 Periodic Safety Update Reports (PSUR)
 Development Safety Update Report (DSUR)
  • Ensure that any request from the competent authorities for the provision of additional information necessary for the evaluation of the risks and benefits of a medicinal product is answered fully and promptly, including the provision of information regarding the volume of sales or prescriptions for the medicinal product concerned.
  • Provide the competent authorities, with any other information that may be relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on PASS.
  • Ensure that all products in scope are continuously evaluated. The EU QPPV is actively involved in safety issue management.
  • Ensure the continuing evaluation of the benefit/risk analyses of all products in scope Ensure that signal detection and trending mechanisms are in place. Ensure that when a safety signal or alert is identified all appropriate actions are initiated in accordance with the relevant procedures.
  • Integrate the PV processes into an appropriate Quality Management System (of Arriello and Client), i.e. adequate Quality system documents, training, compliance measurements and system audits.
  • Provide input into contractual arrangements – SDEAs with business partners, project specific agreements with service providers and PV service agreements between Arriello and Client
  • If the conditions for an Emerging Safety Issue are fulfilled, ensure that the EMA and Health Authorities in relevant countries are contacted immediately ensuring prompt evaluation, including potential recall situations.
  • Carry out your accountabilities in close cooperation with the Deputy EU QPPV and Quality Manager of Arriello.
  • Ensure that the conduct of PV and submissions of all PV-related documents is in accordance with legal requirements and Good Pharmacovigilance Practice, EU pharmacovigilance Regulations, Directives and applicable regulations and guidance.
  • Maintain up-to-date knowledge of PV regulations.
  • Ensure back-up procedures are appropriately maintained and tested including PV business Continuity, Disaster Recovery and Deputy EU QPPV
  • Have following responsibilities in connection to the Local Person for Pharmacovigilance (LPPV):
 Maintain an oversight of project specification documents in place
 Be responsible for approval of the vendors contracted/subcontracted for the role of LPPV by cooperating with the Vendor Manager and Head of Local PV Unit
 Oversee the LPPV training and compliance with the LPPV tasks and responsibilities
 Initiates reconciliation reports with the LPPVs according to the agreement
 Assists Quality Manager with audits of the vendors if required
  • Lead by example to ensure effective and cooperative cross-functional teamwork
  • Serve as a functional expert, which includes but is not limited to knowledge of the services required, local laws and regulations
  • Ensure that all processes and all business partners are in compliance with company and regulatory requirements

Apply for this position

Regulatory Affairs Manager

  • Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication;
  • Delivering solutions to stakeholders;
  • Delivering quarterly company expectations.
  • Manage regulatory affairs designated projects;
  • Cooperate and communicate with the assigned Project Managers, clients and vendors representatives;
  • Liaison with international regulatory agencies as appropriate;
  • Develops and execute regulatory strategy and accurate submission planning for designated project;
  • Compile/create registration dossier in the CTD, eCTD or another format according to the current legislative requirements of the given country (eg. non-EU, RoW, etc..) for all types of processes - new registration, renewal, variations, etc…), as per clients need and request;
  • Timely submissions of regulatory applications;
  • Documents publishing
  • Review of all documents prior submission or transfer to authorities/clients;
  • Overseas labelling up-dates;
  • Manage product life-cycle dossier in according with project governance
  • Reports dossier preparation, submission and approval status, according with project governance settings;
  • Ensure proper archiving of all documents submitted to authorities and/or sent to clients;
  • Regular and accurate updating of internal or external reporting documents;
  • Active participation in assessment of impacts and risks resulting from changes in legislation;
  • Maintain and improve the regulatory department system and procedures;
  • Participate in audits if requested;
  • Respects and assume quarterly KPIs;

Apply for this position

Senior Regulatory Affairs Manager (focused on biological products)

Duties and Responsibilities:

  • Manage regulatory affairs designated projects;
  • Cooperate and communicate with the assigned Project Managers, clients and vendors representatives;
  • Liaison with international regulatory agencies as appropriate;
  • Develops and execute regulatory strategy and accurate submission planning for designated project;
  • Provide solutions on complex regulatory issues;
  • Compile/create registration dossier in the CTD, eCTD or another format according to the current legislative requirements of the given country (eg. non-EU, RoW, etc..) for all types of processes - new registration, renewal, variations, etc…), as per clients need and request;
  • Timely submissions of regulatory applications;
  • Review of all documents prior submission or transfer to authorities/clients;
  • Overseas labelling up-dates;
  • Manage product life-cycle dossier in according with project governance
  • Reports dossier preparation, submission and approval status, according with project governance settings;
  • Ensure proper archiving of all documents submitted to authorities and/or sent to clients;
  • Regular and accurate updating of internal or external reporting documents;
  • Active participation in assessment of impacts and risks resulting from changes in legislation;
  • Participate in audits if requested;
  • Develop, maintain and improve the regulatory department system and procedures;
  • Respects and assume quarterly KPIs;

Apply for this position

Senior Regulatory Affairs Manager (focused on clinical trials)

Duties and Responsibilities:

  • Manage regulatory affairs designated projects;
  • Cooperate and communicate with the assigned Project Managers, clients and vendors representatives;
  • Liaison with international regulatory agencies as appropriate;
  • Develops and execute regulatory strategy and accurate submission planning for designated project;
  • Provide solutions on complex regulatory issues;
  • Compile/create registration dossier in the CTD, eCTD or another format according to the current legislative requirements of the given country (eg. non-EU, RoW, etc..) for all types of processes - new registration, renewal, variations, etc…), as per clients need and request;
  • Timely submissions of regulatory applications;
  • Review of all documents prior submission or transfer to authorities/clients;
  • Overseas labelling up-dates;
  • Manage product life-cycle dossier in according with project governance
  • Reports dossier preparation, submission and approval status, according with project governance settings;
  • Ensure proper archiving of all documents submitted to authorities and/or sent to clients;
  • Regular and accurate updating of internal or external reporting documents;
  • Active participation in assessment of impacts and risks resulting from changes in legislation;
  • Participate in audits if requested;
  • Develop, maintain and improve the regulatory department system and procedures;
  • Respects and assume quarterly KPIs;

Apply for this position

Project Management Assistant

  • Assistance with Project Management tasks
  • Administrative work at department – may include, but is not limited to:
  • Editing, scanning, printing and filing/archiving of the documents according to good documentation practice and Arriello quality system;
  • Revision, formatting, editing of functional project documents – templates, tables, reports, manuals and plans;
  • Project specification agreements preparation according to the template, creation of the POs or other documents needed
  • Supporting reports and questionnaires compilation;
  • Project Management department tracking;
  • Administrative support in communication with internal and external vendors
  • Support of Project Managers in running projects
  • Adherence to company’s processes and systems
  • Support in projects compliance monitoring (collecting data, preparation of reports)
  • Organize and maintain project files and keep databases updated

Apply for this position

Operational Director

  • Strategic oversight of all operational delivery in our business to ensure it adopts and utilises best practice models around consulting and servicing for clients in the pharma sector, ensuring we achieve targets in line with budgets and appropriate costing models.
o To deliver these in the future we may look at partnerships, operational locations, functional structures, investments or other to meet our agreed goals.
  • Direct strategic and operational responsibility for the following teams; Pharmacovigilance (PV), Regulatory services (Reg), Quality Management Services (QMS)
  • Participate in SLT (Strategic Leadership Team ) meetings and the agenda items therein to ensure that areas under your control are properly represented.
  • Provide commercial insight into the delivery capacity and future planning for your teams
  • Develop strategic plans and implement developments that improve your team’s capacity. These plans may cover areas; automation, restructuring, utilisation, training, and other as agreed with the SLT
  • Manage outputs from your teams and ensure that performance levels are comparable to our competitors, so that we can effectively compete on client requests, profit margins and standards.
  • As a Leader, act as an advisor for different parts of the business to support your peers.
  • We see that the above will of particular relevance for the operational elements of our PM function, as we develop it further.
  • Collaborate with clients and authorities where needed, to represent your teams and/or to ensure we present a strong and professional front to our stakeholders.
  • Work to design processes that improve utilisation and balance in our delivery teams and manage budgets around headcount so that we have optimal utilisation for our people.
  • Directly manage functional leads for each of your teams and support the management of Deputies and Team Leads where needed
  • Ensure recruitment, training, development, career planning and other processes outlined in our employee offering are maintained, allowing us to compete for talent and get return from our people investments.
  • Support the CEO / COO and your peer group with ideas, knowledge, etc. when the opportunity arises

Apply for this position

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