Senior Pharmacovigilance Business Analyst

hace 2 semanas

Madrid, Madrid, España LEO Pharma AS A tiempo completo

Field of work:
Clinical Development
Posting Date:27 Mar 2024
Location: Madrid 28004, Madrid, Spain

Contract type:
Permanent

Job ID: 2022
Senior Pharmacovigilance Business Analyst

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 maintainsolutions supporting the Global Safety strategy in relation to maximizethevalue of digitalization to ensurefaster data drivendecision making. Facilitate and mature the regulatory partnership with the R&D Outsourcing partner.
  • Together with GSLT, giveinput 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 newhighlevel procedures and principles for known and new activities. Maintain an overview of QMSdocuments.
  • Ensure compliance to pharmacovigilance processes, regulations and guidelines.
  • Ensure and facilitate access to data for endusers to strengthen overview/oversight andd 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
  • Run User AcceptanceTest
  • Coordinate closing windows with R&D Data and Analytics
  • Drive the 3 times/year Veeva upgrades in Veeva in terms of process impact, QMsrelated 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
  • To maintain and approve HALO PVuntil decommission
  • 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 knowhow 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 knowledgesharing

Your qualifications

  • 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
  • Strong Insight into different PV systems
  • 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
  • Good Businessprocess understanding
  • Understand clinical/drug develo

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