Safety Product Analyst & Consultant

Safety Product Analyst & Consultant

Hoffmann-La Roche Ltd | Mississauga (Malton), ON, L4T, CA

Posted 2 days ago

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Description

The Position

Product Development, Approval and License Maintenance (PDALM) - Safety Product Analyst

Who we are

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other's differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing - and is seeking people who have the same goals for themselves.

The Position

As a Safety Product Analyst & Consultant you will be responsible for scoping, planning and supporting the successful implementation of technology solutions by providing business analysis, best practice research, detailed requirements, user stories definition and user acceptance facilitation. You will be required to work closely with Business Users, Product Owners, Product Managers, IT Business Partners and IT Architects to develop a conceptual architecture for these solutions which includes managing and coordination of complex data migration activities among business, internal IT teams and vendors.

Your help will drive successful completion of major projects/programs across portfolios. Your impact may be within or across multiple portfolios and you will champion accountability by example.

You will work in the Safety domain where a major process and technology transformation is happening. You will be a part of the Product Analysis and Consultancy Chapter and will contribute to the definition of the future Pharmacovigilance system landscape.

What you will be working on:

* Actively engage with the Product Owner, Informatics Product Manager and Subject Matter Experts to drive requirements analysis and determine priority and business value

* Translate business strategy into Informatics context and work with IT Product Managers, IT Business Partners and IT Architects to develop enhancement proposals and roadmaps that support the strategy.

* Lead and drive initiative scoping phase. Collaborate with business and informatics stakeholders to identify business needs, lead the business case development for new initiatives including high level solution options and resource estimates. Support the business partner and IT Business Partner to obtain project approval from portfolio committees.

* Being able to plan for complex migration projects (covering the end-to-end process starting from planning to execution)

* Track record in successful migration of high volume data between IT systems in 100% compliance with GxP regulations (Covering all aspects of data migration including successful conclusion of required data testing)

* Create and maintain a high quality, prioritized backlog for products in their scope

* Facilitate interviews and workshop sessions with business users one-to-one and in groups as needed

* On the basis of identified business needs be responsible for establishing fit-for-purpose user requirements and any related documentation as required by CSV, PMM or agile frameworks

* Create as-is and to-be process maps and narratives

* Identify, manage and resolve risks and issues in their assignments

* Contribute to all areas of system implementation including but not limited to vendor interaction, system configuration, change control, qualification, deployment, and training

* Strive for harmonization of business processes across functions, departments and sites by propagating common standardized data models, applications and technologies that are in line with the cross-functional or functional Informatics strategies and architectures.

* Drive cross functional teamwork by collaborating with Product Analysts within Chapter and across Roche to continuously harmonize and further develop skills and working practices specific to the Analysis and Consultancy capability.

The Ideal Candidate

* Has domain knowledge of the Pharmaceutical, Pharma Development or Life Science industry, or from a consulting firm. Pharmacovigilance process knowledge and experience is a must, ideally in the compliance domain.

* Has extensive experience with large projects (large number of stakeholders, multi locations/global footprint, complex enterprise solutions)

* Has excellent communication and influencing skills

* Always demonstrates leadership in his/her assignments, is able to engage a team towards ambitious goals

* Leads activities in multiple projects/programs: fully accountable for planning, delivery, influencing Project Mgmt, making decisions on behalf of business

* Has a good understanding of Database concepts in specific Entity Relationship Model, Normalization and referential integrity

* Technical hands-on experience in managing or configuration of Pharmacovigilance and PV Systems (e.g. ArisG LSMV/ARGUS/Veeva Safety Vault, etc.)

* Was a major contributor in complex data migration projects (either in planning, defining and maintaining requirements)

* Has solid experience in managing requirements in JIRA

* Can create project plans using MS Projects or Smartsheet

* Ability to author/update documentation with sufficient rigor for GxP

* Exhibits strong soft skills typically required as an Analyst (i.e. active listening, challenging the status quo, ability to communicate complex information, issues, and potential solutions to stakeholders)

* Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business.

* Has experience working in agile environments and exhibits a mindset in the approach to:
* Enable a diverse group of partners to speak with a single voice

* Ensure the right information is available to the development team in the right level of detail at the right time so that the product can be developed.

If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.

To be considered for this position, please apply using the link below.

When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.

Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.