Senior Pharmacovigilance Business Analyst

7 miesięcy temu

Gdańsk, Polska LEO Pharma Pełny etat
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
  • 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, 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
  • 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 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

 

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 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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