Senior Pharmacovigilance Business Analyst

2 tygodni temu

Gdańsk, Pomerania, Polska LEO Pharma Pełny etat
Your role

The 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 the strategy for Veeva Safety Database Support and other systems in GSuntil decommission related activities. Additionally, you'll enhance existing procedures, develop new high-level procedures, and keep an overview of QMS documents. Ensuring compliance with pharmacovigilance processes, regulations, and guidelines, you'll streamline data access to empower end-users for better decision-making in Global Safety.

Global Safety Business Intelligence & Analytics

  • Lead the definition of business requirements for new data reports/visualizations/analytics along with LoB
  • Develop and maintain data reports/visualizations/analytics with LoB
  • Prepare ad hoc data extraction queries and reports upon LoB's request
  • Support LoB with functional data analyses as needed
  • Identify and kickstart process and workflow procedure enhancements
  • Drive the change management of PV systems in affected departments

Drive the processes concerning Veeva updates

  • Assess GS process impact based on R&D data and Analytics digests
  • Identify and implement QMS changes as required
  • Provide input on R&D Data and Analytics relevant test cases
  • Conduct User Acceptance Tests
  • Coordinate Veeva upgrades and relevant tasks with R&D Data and Analytics
  • Oversee the 3 times/year Veeva upgrades regarding process impact, QMs-related updates, and user Acceptance Tests
  • Collaborate with pertinent GS Subject Matter Experts

Global Safety Systems and Solution Projects and Activities

  • Prepare and deliver project deliverables according to project timelines
  • Coordinate assigned activities by line manager or project lead
  • Serve as Subject Matter Expert (SME)
  • Facilitate defining user requirements and specifications with LOB
  • Maintain and approve HALO PV until decommission
  • Drive HALO PV upgrades as needed until decommission

Outsourced Portfolio for Global Safety

  • Support vendor governance for all GS tasks
  • Establish the business link between GO and the business liaison
  • Train the trainer for new activities
  • Escalate issues to the business liaison
  • Assist in resolving issues between GS and the Partner
  • Communicate status, issues, decisions, and actions to relevant stakeholders
  • Support expanding the operating model with new tasks moving to the outsourced Portfolio
  • Provide input on new activities
  • Facilitate and improve the partnership but not replace the Partner in tasks/issues

Other Relevant Activities

  • Compliance with applicable LEO SOPs
  • Contribute to the maintenance of departmental systems
  • Represent the department in cross-departmental teams
  • Ensure proper handling of safety data in the safety database
  • Communicate safety issues internally and to health authorities
  • Represent GS at Health Authority meetings as necessary
  • Stay updated on professional information and tech through literature, workshops, conferences, etc.
Your qualifications

To excel in this role, we expect you to possess the following qualifications:

  • Relevant health science background, e.g., H P with a minimum of 2 years experience in a project-oriented, international organization preferably in pharmacovigilance
  • Strong computer literacy and safety database knowledge
  • Thorough understanding of EMA/ICH/FDA guidelines
  • Insight into various PV systems
  • Ability to analyze and interpret data effectively
  • High level of accuracy, integrity, and quality in work practices
  • Excellent communication skills, both oral and written
  • Proficient in medical terminology
  • Fluency in verbal and written English
  • Strong multitasking, organization, prioritization, and proactive thinking
  • Solid understanding of business processes
  • Familiarity with clinical/drug development processes/functions and appropriate interaction
  • Strategic thinking, influencing skills, and collaboration abilities
Your application

You are not required to upload a cover letter, but you can include a few sentences in your resume or CV explaining why this position interests you.

Beyond the Skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to create a lasting impact. Our innovative approach sets us apart, and we are committed to leaving a positive legacy that benefits patients, colleagues, and the environment. At LEO Pharma, we believe in individual empowerment to drive change. Our flat organizational structure allows you to make a tangible impact and offers various opportunities for professional development. We embrace diversity and invite applications from all qualified candidates, understanding that our diverse perspectives enhance our decision-making. Join the passionate team at LEO Pharma and contribute authentically as we strive to make a meaningful difference. Background checks by a third party may be conducted for specific roles.

Embark on our journey Beyond the Skin. Submit your application today.

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