Multiethnic modern business team developing the company's strategy at the office

Software Developer

Careers at Bonafi

Software Developer

Bulgaria – Full time – Software development – Experienced

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Introduction

Bonafi is an exciting early-stage RegTech startup for Life Sciences. We are on a mission to help companies in the pharmaceutical industry manage the end-to-end qualification cycle of their customers and suppliers by introducing automation and digitalization to a very manual process.

We believe that respect is the foundation of a healthy workplace; respect for each other’s opinions, backgrounds, and values. We seek out diversity realizing that people coming together from different walks of life enable innovation and propel growth.

Overview of the job’s responsibilities:

Bonafi is seeking an experienced software developer who can contribute to innovative solutions. A Software Developer at Bonafi will work hand-in-hand with our designers, QA Teams, and stakeholders to deliver a timely, high-quality product.

Who will love this job?

We believe that this job is for someone who would like the chance to make a big individual impact with autonomy and responsibility.

The ideal candidate is a self-motivated, multi-tasker, and demonstrated team player. Someone who thrives in a startup environment and can contribute to original ideas and take ownership.

You will be a developer responsible for the development of new software products and help shape our future solutions.

What you’ll be responsible for:
  • Writing clean, high-quality, high-performance, maintainable code
  • Technical documentation
  • Develop and support software including applications, database integration, interfaces, and new functionality enhancements
  • Coordinate cross-functionally to insure project meets business objectives and compliance standards
  • Support test and deployment of new products and features
  • Participate in code reviews
What we look for in a candidate:
  • Fluent in English
  • Good communication skills are essential.
  • Bachelor’s degree in Computer Science (or related field)
  • 3+ years of relevant work experience
  • Professional expertise in Object-Oriented Design and Database Design
  • Professional experience in AWS, Java, Springboot, Vue & Python
  • Some experience with infrastructure technologies (Linux, Docker & Kubernetes)
  • Experienced documenting systems, processes, and solutions
  • Professional experience designing and developing APIs via REST and JSON (Bonus: written in NodeJS)
  • SQL database and noSQL e.g. MongoDB
  • Experience with Agile or Scrum software development methodologies
  • Ability to multi-task, organize, and prioritize work
  • Experience working with Pharma GxP software is a bonus

Apply for this position

National Startup Awards 2021

Bonafi takes Bronze in the National Startup Awards 2021!

Bonafi takes Bronze in the National Startup Awards 2021!

We are so proud to have won Bronze in the National Startup Awards 2021 in the best Medtech Startup Category.

The recognition goes a long way and it is very rewarding after all the hard work the entire team has put in. Starting a business and building new technology, is most certainly not the easiest path forward. But these types of acknowledgments make all the difference.

A big thank you to everyone in the Bonafi team that has supported us along the way and worked so hard on this.  Also a bit thank you to the National Startup Awards 2021 and all the sponsors that make the Irish Startup Ecosystem glow!

Global Connection Background Through the Whole World, 3d illustration

Digital Transformation continues to be in focus – but how about culture?

Digital Transformation continues to be in focus – but how about culture?

In a pre-COVID 2019 Survey of global pharmaceutical industry professionals, GlobalData reported that less than half of its respondents had a digital strategy in place and 19% had no plans to implement.[1]

Two of the largest barriers hindering digital transformation in pharma, according to industry professionals, was due to organizational and cultural challenges along with technology integration challenges. This is consistent with McKinsey’s findings from 2016. [2] This situation isn’t exclusive to the pharmaceutical industry. Harvard Business Review reported findings from a 2020 survey across multiple sectors that culture was indeed a contributing barrier to digital transformation.[3]

The pandemic, however, has forced us to take a giant step into a digital and virtual world to perform our day-to-day activities and to ensure business continuity. In fact, in a 2021 survey – GlobalData reported that 35% of pharmaceutical industry professionals believe that digital transformation is accelerated in the pharmaceutical industry by more than five years.[4]

Does this mean that our culture has changed? Ask anyone who has had to virtually perform supplier quality audits of companies with paper-based processes; or those who are frustrated by having to trawl through various sources (paper documents, emails, share points etc.) to find due diligence information. They would likely be the first ones to ask for change and feel that a digital transformation couldn’t come soon enough.

However, according to Harvard Business Review’s study – 46% of the surveyed professionals continue to experience culture as a barrier.[5]  This is not surprising given that it can take several years to change an entire organizational culture. As a part of that cultural change, technology must be integrated across all aspects of the business. 89% of the surveyed professionals believe that a successful implementation depends on having a combination of the right culture, the right processes, and the right technology in place.[6]

Peter Drucker coined the phrase “culture eats strategy for breakfast” – clearly that includes digital strategy. Does your pharma organization have the right culture in place to fully embrace digital transformation?

………………………………….

[1] “Digital Disruption is knocking – is healthcare ready?”, GlobalData Presentation CPhI Worldwide 2019, Bonnie Bain, 2019

[2]https://www.mckinsey.com/industries/life-sciences/our-insights/closing-the-digital-gap-in-pharma,

[3] “Accelerating Transformation for a Post-Covid-19 World”, Harvard Business Review Analytic Services, 2021

[4]https://www.globaldata.com/covid-19-accelerated-digital-transformation-timeline-pharmaceutical-industry/

[5] “Accelerating Transformation for a Post-Covid-19 World”, Harvard Business Review Analytic Services, 2021

[6] Ibid;

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Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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EudraGMDP Screen

EudraGMDP: database to be integrated with EMA’s Organisation Management Service (OMS)

EudraGMDP to be integrated with EMA’s Organisation Management Service (OMS)

Regulations 2019/6 and 2021/16, Article 9(h)  |   05 October 2021 

As communicated by EMA:

“The new regulatory framework for veterinary medicines requires several changes to EudraGMDP. The most notable change is the integration of EudraGMDP with EMA’s Organisation Management Service (OMS).

From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS).

It is therefore necessary that all organisations currently regulated through EudraGMDP (which appear on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances) are registered in OMS.”

The development of the database – the Manufacturers and Wholesale Distributors database (MWD) – started on 1 July 2021 and is currently in its test phase.

Status – EudraGMDP to OMS Integration (source: Veterinary Medicinal Products Regulation HIGHLIGHTS, European Medicines Agency, Issue 6, July 2021)

What is the Organisation Management Service (OMS)?

As per EMA the “OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes.

It stores master data comprising organisation name and location address for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers. “

OMS has published a Data Quality Standard and integrating EudraGMDP with OMS should ensure more reliable data in the system through the consistent use of organisation master data in EudraGMDP.

What does this mean for access to public data in EudraGMDP?

Our understanding is that “access will continue as before – no changes are foreseen”.  

Webinar

The EMA will organise a webinar on the OMS services for interested manufacturers, importers and distributors on 12 October 2021 at 14:00 – 16:30 CEST. Participants will have the chance to ask questions and seek clarifications on OMS services and activities.

Supplier Qualification Life Cycle

Supplier Qualification: new chapter by U. S. Pharmacopeia

Supplier Qualification – new chapter by U. S. Pharmacopeia

<1083> Supplier Qualification – PF 47(5)   |   03 October 2021

The US Pharmacopeia is proposing a new informational chapter on Supplier Qualification – <1083>. This was previously published as a chapter on good distribution practices and now <1083> is repurposed to focus on a risk-based approach to Supplier Qualifications.

The initiative has its roots in a white paper  “Good Supply Practices for the 21st Century”, published by Xavier Health in 2018 and will discuss the importance of supplier qualification and the application of a quality risk-based approach. 

The chapter outlines examples of supplier types that should be qualified, a six-step process of Supplier Qualification Life Cycle Management along with points to be considered in a risk assessment broken down by risk category.

While the USP general chapters numbered <999> and above are general guidelines rather than being enforceable by law, <1083> contains some good indications on the use of risk-based supplier qualifications. Commenting on <1083> is open until 30 November 2021.

NOTE: To access the document requires an account with USP- which can be created for free on the USP website.

Covid-19 vaccine with ‘fake’ stamp

Council of Europe: Covid-19: what measures to fight against fake vaccines?

Council of Europe: Covid-19: what measures to fight against fake vaccines?

Strasbourg   |   27/04/2021

“Amid the rise in counterfeiting and other illegal activities related to the Covid-19 pandemic, the Council of Europe is issuing new recommendations to governments based on its Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention).

As regulators around the world approve more vaccines for sale, reports of seizures of counterfeit vaccines continue to rise.

In an opinion published today, the MEDICRIME Committee sets out 13 measures to prevent and combat the presence of counterfeit vaccines on the market, including vaccines that misrepresent their identity and/or source, as well as the diversion of legally produced vaccines from the legal supply chain.

The Committee proposes preventive measures in co-operation with the relevant sectors to strengthen the supply chain, ensure the authenticity of vaccines, and improve arrangements for the disposal of Covid-19 vaccine waste.

The Committee also emphasises the importance of training relevant government officials (customs officers, police and judges) and raising public awareness.

Background

The only international treaty of its kind, the 2011 Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention) has been ratified by 18 countries and signed by 15 others in Europe and beyond.

The Convention provides a framework for national and international co-operation between the competent health, police and customs authorities at both national and international level, measures for crime prevention by also involving the private sector, and the effective prosecution of crime and the protection of victims and witnesses.

In 2020, the MEDICRIME Committee published an opinion on the application of the Convention in the context of Covid-19.

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Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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680

Digital strategy in pharma: GAMP Francophone position paper on CSA

Digital strategy in pharma:
GAMP Francophone position paper on CSA

GAMP Francophone Position paper on CSA – Computer Software Assurance

In light of the COVID-19 pandemic, too low levels of adopting a digital strategy in the pharmaceutical industry and the prevalence of paper-based processes in the validation of applications and processes , GAMP Francophone, has published a position paper on US-FDA’s initiative on CSA – Computer Software Assurance. The CSA is a prioritized guidance document, intended to be published in FY2021by the FDA. The new guidance is intended to shift the focus of the document-oriented computer validation towards a risk-based, critical thinking approach.

The position paper observes that the practices in the healthcare industry “show a certain difficulty, or even inability, to take advantage of technological developments and alternative project management approaches”

The paper stresses the importance of not immobilizing the technical and digital evolution while waiting for FDA’s new guidance document on CSA– but meticulously plan for the anticipated progress and take the opportunity to invest in the understanding of new technologies. It also underlines that the current European regulatory framework “through its systematic consideration of quality risk management”, currently do provide generous amplitude for implementing new and innovative approaches and that GAMP5 in a similar manner encourages creativity and efficiency in their industry practices.

As a company developing digitized compliance solutions to the pharmaceutical industry which will be validated, we are certainly looking forward to the published guidelines.

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Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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Screenshot 2020-10-19 at 13.37.41

Featured in Thinkbusiness.ie

Bonafi Featured in Thinkbusiness.ie

Glad to be the Editor’s Pick in this morning’s Business Planning section of Thinkbusiness.ie.

You can find a link to the article on the right.

 

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Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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Screenshot 2020-10-15 at 22.02.13

Interview with DublinBIC

Talk with Dublin BIC

I was invited by Dublin BIC to talk about Bonafi, patient safety, and falsified medicines. Our conversation sheds light on why it is important to know who your pharma customers and suppliers are, and how patients could be put at risk if the due diligence is not carried out.  We also discussed the potential risks that have emerged as a result of COVID-19. 

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Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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Regional Finalist - Transparent background

Seedcorn Competition

Regional Finalist in the Seedcorn Competition!

Really glad to announce that Bonafi is one of the regional finalists for Dublin as a start-up in the biggest business competition across Ireland and Northern Ireland for an innovative new start and early-stage businesses in any sector.

Bonafi will go on to compete in the Seedcorn Final and the winner is announced on the 26th November. Stay tuned and wish us good luck!

NEWS

FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH