Senior Pharmacovigilance Business Analyst

5 dni temu

Gdańsk, Pomerania, Polska TN Poland Pełny etat

Social network you want to login/join with:

Client:

LEO Pharma

Location:Job Category:

Other

EU work permit required:

Yes

Job Reference:

b44bdddbc87c

Job Views:

24

Posted:

23.01.2025

Expiry Date:

09.03.2025

Job Description:Your role

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

Together with GSLT, provide input to the strategy for Veeva Safety Database and support other systems in GSuntil decommission e.g. HALO PV Challenge. 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 with pharmacovigilance processes, regulations, and guidelines.

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

Global Safety business intelligence & analytics

  • Lead definition of business requirements/needs for new data reports/visualizations/analytics in collaboration with LoB.
  • Develop and maintain data reports/visualizations/analytics in collaboration with LoB.
  • Prepare ad hoc data extraction queries and reports on request from LoB.
  • Support LoB with functional data analyses as required.
  • Identify and initiate process and workflow procedure improvements.
  • Drive change management of the PV systems in impacted departments.

Drive the processes in relation to Veeva updates

  • Assess GS process impact based on R&D Data and Analytics digest.
  • Identify and drive QMS changes as relevant.
  • Provide input to R&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.
  • 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 and 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 link between 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 of status, issues, decisions, and actions to relevant stakeholders.
  • Support expansion to the operating model with new tasks moved to the outsourced Portfolio, when decided by GS.
  • Provide input to new activities.
  • Not a substitute for the Partner, i.e. solving the tasks/issues for the Partner, but to facilitate and mature the partnership.

Other relevant activities

  • Comply with applicable LEO SOPs.
  • Contribute to the maintenance of department systems.
  • Represent the department in cross-departmental teams.
  • Ensure correct handling of safety data in the safety database (including know-how on all case handling processes).
  • Communicate safety issues internally and 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. HP with a minimum of 2-year experience working in a project-oriented, international organization preferably in pharmacovigilance.
  • Strong computer literacy and knowledge of safety databases.
  • Strong understanding of EMA/ICH/FDA guidelines.
  • High ability to analyze and interpret data.
  • High level of accuracy, integrity, and quality in work practices.
  • Good communication skills, oral and written.
  • Competent knowledge of medical terminology.
  • Proficient in verbal 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

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