Operations Specialist 1 in Regulatory Reporting

3 weeks ago


Dublin, Dublin City, Ireland Pharmiweb Full time
IQVIA Safety Operations – Regulatory Reporting team play an important part in execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. Each new joiner is supported by a nurturing management team, collaborative colleagues as well as a clear career ladder with plenty of opportunities to allow you to grow, adapt and shine.

We are looking for the best talent, with English language expertise to be part of a global team that partnership with a major pharmaceutical company, working with patient safety on post-market products. Apply your knowledge and expertise, including complex decision making, to review, assess and process safety and product quality information.

Safety Operations Specialist in Regulatory Reporting with English language

Review, assess and process safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties, following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Key responsibilities:

  • Process safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  • Perform Pharmacovigilance activities per project requirement; collecting and tracking incoming Adverse Events(AE)/endpoint information, determining initial/update status of incoming events.
  • Receive, review and interpret medical reports.
  • Ensure to meet quality standards per project requirements.
  • Ensure to meet productivity and delivery standards per project requirements.
  • Assure compliance to all project related processes and activities.
  • Create, maintain and track cases as applicable to the project plan.
  • Prioritize and complete the assigned trainings on time.
  • Identify quality problems and bring them to the attention of a senior team member.
  • Code AE and Products, write narratives and perform Literature related activities as per internal/ project timelines.
  • Attend project team meetings and provide feedback to operations manager on any challenges or successes.

Minimum Required Education and Experience

  • Must be fluent in English language (min. C1)
  • Bachelor's Degree in Life Sciences or Healthcare discipline is a must.

Skills and Abilities

  • Excellent attention to detail and accuracy.
  • Good knowledge of medical terminology.
  • Ability to follow instructions/guidelines, utilize initiative and work independently.
  • Effective verbal and written communication skills.
  • Ability to manage competing priorities.
  • Strong presentation skills; report writing skills and customer focus skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers.
  • Self-motivated and flexible.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at



  • Dublin, Dublin City, Ireland IQVIA Full time

    IQVIA Safety Operations – Regulatory Reporting team play an important part in execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. Each new joiner is supported by a nurturing management team, collaborative colleagues as well as a clear career ladder with plenty of opportunities to...


  • Dublin, Dublin City, Ireland Robert Walters Ireland Full time

    Experience Level: /experience-level/MidManagement Location: Dublin City Centre Contract type: FULL_TIME Specialism: Accountancy & Finance Focus: Finance Manager Industry: Banking Salary: Negotiable Workplace Type: /remote-working/Hybrid Experience Level: /experience-level/MidManagement Location: Dublin City Centre FULL_TIME Consultant: Luke...


  • Dublin, Dublin City, Ireland Avature Full time

    When you join KPMG Ireland, you are joining a community of over 4,200 employees who collectively work together, both in person and virtually, to achieve their full potential. We are known as an organisation who want you to come as you are and do work that truly matters. Joining KPMG Ireland is an opportunity to enhance your career, not only in the work...


  • Dublin, Dublin City, Ireland Fineco Asset Management Full time

    Operations Regulatory Reporting Analyst/Senior AnalystFineco Asset Management DAC Fineco Asset Management DAC ('FAM') is a Dublin based asset management subsidiary of FinecoBank S.p.A. ("FinecoBank"). FinecoBank ("Fineco") is a leading European bank with a 20 year history and a fully digital DNA with a branchless approach since the start.FAM, which started...


  • Dublin, Dublin City, Ireland Oliver James Associates Ltd. Full time

    Oliver Jmaes are keen to speak with accountants on behalf of our client, a leading company in the Insurance industry. They are currently seeking a Regulatory Reporting Accountant to join their Finance team. The role sits on a regional team and supports the Head of the function.Role & ResponsibilitiesPrepare and submit accurate and timely regulatory reports...


  • Dublin, Dublin City, Ireland Bank of Ireland Full time

    What is the Opportunity? An exciting opportunity to join the Regulatory Reporting Change Team, a sub team within RRCO, is responsible for the development and delivery of strategic reporting solutions to meeting new, and amended, regulatory reporting requirements and to deliver of Bank change projects across regulatory reporting processes. With the ever...


  • Dublin, Dublin City, Ireland Bank of Ireland Full time

    What is the Opportunity? An exciting opportunity to join the Regulatory Reporting Change Team, a sub team within RRCO, is responsible for the development and delivery of strategic reporting solutions to meeting new, and amended, regulatory reporting requirements and to deliver of Bank change projects across regulatory reporting processes. With the ever...


  • Dublin, Dublin City, Ireland Bank of Ireland Full time

    What is the Opportunity? An exciting opportunity to join the Regulatory Reporting Change Team, a sub team within RRCO, is responsible for the development and delivery of strategic reporting solutions to meeting new, and amended, regulatory reporting requirements and to deliver of Bank change projects across regulatory reporting processes. With the ever...


  • Dublin, Dublin City, Ireland Us Bank Full time

    At U.S. Bank, we're on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions, enabling the communities we support to grow and succeed in the right ways, all more confidently and more often—that's what we call the courage to thrive. We believe it takes all of us to bring our shared ambition to...


  • Dublin, Dublin City, Ireland Software Placements Full time

    Client:Our client a leading Multinational Financial Services Organisation requires Contract Regulatory Reporting Data Consultant for 9 month daily rate position based in the IFSC, Dublin 1, Ireland.Role:You will be responsible for the upgrading of processes using digitization tools such as Alteryx and Workiva. In addition, the consultant will support the...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Senior Regulatory Affairs SpecialistOur client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the...


  • Dublin, Dublin City, Ireland Bank of Ireland Full time

    What is the opportunity? This is a highly sought-after and topical role within the banking sector which will offer you the opportunity to engage with colleagues across the organisation and also increase their profile with Senior Management. You will become part of a fast-moving team focusing on ensuring the Group is reporting risk-weighted assets & Capital...


  • Dublin, Dublin City, Ireland Dye & Durham Corporation Full time

    Report Specialist - Dublin - Hybrid (1 day a week WFH)WHO ARE WE? Are you looking to build an exciting and dynamic career at a company with prestigious blue-chip clients and international reach? Dye & Durham, a leading global provider of cloud-based software and technology solutions, is focused on an unwavering commitment to customer excellence and to the...


  • Dublin, Dublin City, Ireland SEI1GLOBAL Full time

    JOB DESCRIPTION SEI Investments is a leading global provider of asset management and investment technology solutions.The company's innovative solutions help corporations, financial institutions, financial advisors, and affluent families create and manage wealth. SEI is a people focused organization which encourages and recognizes employee development as...


  • Dublin, Dublin City, Ireland SEI Investments Company Full time

    SEI Investments is a leading global provider of asset management and investment technology solutions.The company's innovative solutions help corporations, financial institutions, financial advisors, and affluent families create and manage wealth. SEI is a people focused organization which encourages and recognizes employee development as being a critical...


  • Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full time

    We have a new opening for aRegulatory Affairs Specialistto join a well-established but rapidly growing international healthcare business based inTullamore, Co Offaly. It is a great chance to be part of an organization that makes a real impact on millions of lives. The company have asignificant presence in Ireland the UK and mainland Europe. This is...


  • Dublin, Dublin City, Ireland Davy Group Full time

    Davy is a trusted market leader in wealth management and capital markets, building rewarding relationships that last. Our vision is to be the financial services partner most trusted by our clients and most admired for our people. We are committed to delivering world-class outcomes for our clients – whether they are individuals, businesses or...


  • Dublin, Dublin City, Ireland Citigroup Full time

    Are you looking for a career move that will put you at the heart of a global financial institution? Then bring your skills to the Citi's Controllers organisation team.By Joining Citi, you will become part of a global organisation whose mission is to serve as a trusted partner to our clients by responsibly providing financial services that enable growth and...


  • Dublin, Dublin City, Ireland Cook Medical Incorporated Full time

    OverviewThe Post Market Surveillance Specialist acts as a go-between the Cook manufacturer, Cook local affiliates, and regulatory authorities. Responsible for assessing complaints for Regulatory Reporting, including Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action, and related correspondence to...


  • Dublin, Dublin City, Ireland Cook Medical Incorporated Full time

    OverviewThe Post Market Surveillance Specialist acts as a go-between the Cook manufacturer, Cook local affiliates, and regulatory authorities. Responsible for assessing complaints for Regulatory Reporting, including Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action, and related correspondence to...