Senior Pharmacovigilance Business Analyst

2 tygodni temu

Gdańsk, Pomerania, Polska LEO Pharma AS Pełny etat

Select how often (in days) to receive an alert:

Senior Pharmacovigilance Business Analyst

Field of work: Clinical Development

We are looking for our new Senior Pharmacovigilance Business Analyst.

At LEO Pharma, we are on a transformative journey to solidify our position as a global leader in medical dermatology.

In the global safety operations department you are empowered for visible impact and are guided by our winning behaviors of simplification, collaboration, and accountability to achieve our goals.

Your role

The overal objective of this role is to assess, develop, implement and maintain solutions supporting the Global Safety strategy in relation to maximize the value of digitalization to ensurefaster data driven decision making. Facilitate and mature the regulatory partnership with the R&D Outsourcing partner.

Together with GSLT, give input to the strategy for Veeva Safety Database Support other systems in GSuntil decommission e.g. HALO PV Challenge and significantly improve existing procedures and develop new high-level procedures and principles for known and new activities. Maintain an overview of QMS documents.

Ensure compliance to pharmacovigilance processes, regulations and guidelines.

Ensure and facilitate access to data for end-users to strengthen overview/oversight and at a driven decisions in Global Safety.

Global Safety business intelligence & analytics

  • Lead definition of business requirements/needs for new data reports/visualisations/analytics in collaboration with LoB
  • Develop and maintain data reports/visualisations/analytics in collaboration with LoB
  • Prepare a d hoc data extractionqueries and reports on request from LoB
  • Support LoB with functional d a t a analyses a s required
  • Identify and initiate process and workflow procedure improvements
  • Drive the change management of the PV systems in impacted departments

Drive the processes in relation Veeva updates

  • Assess GS process impact based on R&DD at a and Analytics digest
  • Identify and drive QMS changes as relevant
  • Provide input toR&D Data and Analytics relevant test cases
  • Coordinate closing windows with R&D Data and Analytics
  • Drive the 3 times/year Veeva upgrades in Veeva in terms of process impact, QMs-related updates and performance of user Acceptance Tests "ever green maintenance
  • Coordinate with relevant GS SMEs

Global Safety systems and solution projects and activities

  • Prepare and deliver project deliverables in accordance with project timelines
  • Coordinate activities as allocated by line manager or project lead
  • Act as SME
  • Facilitate definition of user requirements a n d specifications in collaboration with LOB
  • Drive HALO PV upgrades as required until decommission

Outsourced portfolio for Global Safety

  • Support governance of Vendor for all GS tasks
  • Act as the business linkbetween G O and the business liaison
  • Train the trainer in new activities
  • Escalate issues to the business liaison
  • Support the facilitation of issue management from escalated to resolution between GS and the Partner
  • Support the communication ofstatus, issues, decisions and action to relevant stakeholders
  • Support expansiont ot h e operating model with "new tasks moved to the outsourced Portfolio, when decided by GS
  • Give input to new activities
  • Not a substitute for the Partner, i.e. solving the tasks/issues for the Partner, but tofacilitate and mature thepartnership

Other relevant activities

  • To comply with applicable LEO SOPs
  • To contribute to the maintenance ofdepartment systems
  • To representthedepartment ni crossdepartmentalFeams
  • To ensure correct handling of safety data ni the saintvologtabase (including know-how on all case handling pegansesskin
  • To communicate safety issues internally a n d to health authorities
  • Representing GS at Health Authority meetings, as required
  • Keep abreast of professional information and technology through literature, workshops, conferences and general knowledge-sharing

To succeed in this role, we imagine that you have the following qualifications:

  • Required education : Relevant health science background, e.g. H P with a minimum of 2-year experience working in a project oriented, in- ternational organisation preferably in pharmacovigilance.
  • Strong computer literacy and knowledge of safety databases
  • Strong understanding of EMA/ICH/FDA guidelines
  • High Aility to analyses and interpret data
  • High level of accuracy, integrity, and quality in work practices
  • Good communicationskills, oral and written
  • Competent knowledge of medical terminology
  • Proficient inverbal and written English
  • Strong multitasking, organization, prioritization, and ability to think ahead
  • Understand clinical/drug development processes/functions and interact appropriately
  • Fluent verbal and written English
  • Strategic thinking, influencing, and collaboration
Your application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

Join us on our journey Beyond the Skin. Apply today

#J-18808-Ljbffr

  • Senior Pharmacovigilance Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska LEO Pharma Pełny etat

    Your roleThe main goal of this position is to evaluate, create, execute, and sustain solutions that support the Global Safety strategy to enhance the benefits of digitalization for faster data-driven decision-making. You'll work on strengthening the regulatory partnership with the R&D Outsourcing collaborator. Collaborating with GSLT, you'll contribute to...

  • Senior Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Polpharma Biologics Pełny etat

    Polpharma BiologicsWe are seeking a Senior Business Analyst to lead financial analyses in the areas of biotechnological manufacturing and inventory management. This pivotal role will be instrumental in shaping the future of biotechnological manufacturing within our company by overseeing and driving the optimization of costs of goods. The ideal candidate will...

  • Senior Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska KPMG Pełny etat

    Senior Business Analyst (Data governance) w Zespole Data Intelligence Solutions Miejsce pracy: Gdańsk Technologie, których używamy Wymagane Microsoft Purview Collibra O projekcie W zespole Data Intelligence Solutions dostarczamy usługi z zakresu opracowywania strategii wykorzystania danych, wdrożenia platformy danych, rozwiązań Business Intelligence...

  • Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Banqsoft Pełny etat

    Who we're looking forWe're excited to announce an opportunity for a Business Analyst. As a Business Analyst, you develop and deliver client specific solutions in close collaboration with the development team. The Business Analyst are responsible for analysing business processes, identifying areas for improvement, and proposing innovative solutions. To be...

  • Senior Business System Analyst and Developer, Officer

    2 tygodni temu

    Gdańsk, Pomerania, Polska STATE STREET CORPORATION Pełny etat

    Senior Business System Analyst and Developer, Officer page is loaded Senior Business System Analyst and Developer, Officer Apply locations Gdansk, Poland time type Full time posted on Posted 2 Days Ago job requisition id R Role Summary:The successful applicant will be required to work within a team structure, in delivering a high value service and in...

  • Senior Data Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Belmont Lavan Ltd Pełny etat

    Senior Data Analyst - RemoteAbout the Company:Belmont Lavan Ltd is a leading data-driven company that specializes in addressing environmental challenges. We are dedicated to using data to drive positive change and contribute to a sustainable future. We are currently looking for a Senior Data Analyst to join our team.Job Description:As a Senior Data Analyst,...

  • Business Analyst 14105

    2 tygodni temu

    Gdańsk, Pomerania, Polska b2bnetwork Pełny etat

    Detailed description of work task to be carried outJob description: Advanced Business Analyst who has profound experience in doing data Analysis using SQL. Knowing SAS/Python is an added advantage. Well versed and comfortable in handling Huge Datasets. Good Analytical and problem-solving skills. Should be able to understand the Business terminologies and act...

  • Senior Business Analyst SQL, SAS, Python Warszawa, Gdańsk 12.03.2024

    2 tygodni temu

    Gdańsk, Pomerania, Polska DCG Poland Pełny etat

    DCG is a modern technology company, gathering in its ranks IT related professionals. Due to the continuous development and the large number of recruitment projects that we carry out for our Partners, we are looking for a person for the position:Senior Business AnalystResponsibilities:Working with technical requirement specifications in close collaboration...

  • Financial Risk Reporting Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska myGwork - LGBTQ+ Business Community Pełny etat

    An experienced professional to join the team as Assistant Vice President - Financial Risk Reporting based in the Poland. This role is part of the Global Risk Operations Group within Enterprise Risk Management's Financial Risk Organization. The goal of ERM is to ensure that State Street's risks are proactively identified, well-understood, and prudently...

  • Senior Decision Support Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Acxiom Pełny etat

    Senior Decision Support Analyst page is loaded Senior Decision Support Analyst Apply locations Gdańsk time type Full time posted on Posted 30+ Days Ago job requisition id JR010582 As a Senior Decision Support Analyst focused on Email Marketing campaigns you will work closely with the team of email marketing and data experts. You will ensure that Acxiom...

  • Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Lyreco Group (Italy) Pełny etat

    As a Business Analyst/Configuration Administrator, you will play a crucial role in deploying and maintaining Microsoft Dynamics 365 solutions tailored for our customer service operations. This position involves close collaboration with both local and central business and IT teams to propose solutions, configure, and optimize our Dynamics 365 environment to...

  • Senior Data Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Belmontlavan Pełny etat

    About the Company:Belmont Lavan Ltd is a leading data-driven company that specializes in addressing environmental challenges. We are dedicated to using data to drive positive change and contribute to a sustainable future. We are currently looking for a Senior Data Analyst to join our team.Job Description:As a Senior Data Analyst, you will be responsible for...

  • Senior It Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Emagine Sp. Z O.o. Pełny etat

    Technologies-expected : Jira Confluence technologies-optional : SQL about-project : Industry: Banking Location:Gdansk Remuneration: up to 140 pln/h Type of assignment: B2 B contract As a (Senior) IT analyst, you'll play a valuable role in actively contributing to the collaboration between business and IT, and drive requirement engineering work at...

  • Business Transformation Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Thomson Reuters Pełny etat

    We are looking for a Business Analyst to join our team! Here's what you will do in this role: Analyse current business processes for enhancements. Collect business requirements through workshops and data analysis. Collaborate with stakeholders to align solutions with goals. Aid in project planning and monitoring for successful outcomes. Mitigate...

  • Salesforce Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Capgemini Pełny etat

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Salesforce Business Analyst We work in a hybrid model Recruitment process for this position is conducted online. Software Center is a part of Capgemini Group. We support our clients, using the knowledge, experience, and engagement of our specialists. Our offices are...

  • Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Lyreco Group Pełny etat

    As a Business Analyst/Configuration Administrator at LYRECO, you'll have a key role in deploying and maintaining tailored Microsoft Dynamics 365 solutions for customer service operations. In this position, you'll collaborate closely with local and central business and IT teams to propose solutions, configure, and optimize the Dynamics 365 environment to...

  • Senior System Analyst with integration experience

    2 tygodni temu

    Gdańsk, Pomerania, Polska Sii Sp. z o.o. Pełny etat

    Senior System Analyst with integration experience Gdańsk, Pomorskie technologies-expected :SQLJiraConfluenceabout-project :We are looking for a resourceful and solutions-oriented Senior System Analyst with wide experience in projects related to different systems integrations. You will support our customers with creating an innovative, global e-commerce...

  • Application Manager/Business Analyst

    4 dni temu

    Gdańsk, Pomerania, Polska Nordea Bank Pełny etat

    Job ID: 24702 We are looking for an Application Manager/Business Analyst, to join 'Manage TM Applications' (Manage Transaction Monitoring Applications). The successful candidate will support us in further development and maintenance of FinCrime applications as well as ensure their compliance with business objectives and regulatory requirements. You will...

  • Commercial Business Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Siemens Gamesa Renewable Energy, S.A. Pełny etat

    Commercial Business Analyst page is loaded Commercial Business Analyst Apply locations PL-Gdansk time type Full time posted on Posted 4 Days Ago job requisition id R-41008 It takes the brightest minds to be a technology leader. It takes imagination to create green energy for the generations to come. At Siemens Gamesa we make real what matters, join our...

  • Business Intelligence Analyst

    2 tygodni temu

    Gdańsk, Pomerania, Polska Mr Wolf Pełny etat

    We are looking for a Business Intelligence Analyst with expertise in PowerBI to join our dynamic team. You will be instrumental in developing a PowerBI dashboard that analyzes our clients market positioning in terms of pricing and product availability compared to our competitors.Key Responsibilities:Develop and maintain PowerBI dashboards to display...