Senior Pharmacovigilance Business Analyst

1 dzień temu

Gdańsk, Pomerania, Polska LEO Pharma Pełny etat
Job Summary

We are seeking a highly skilled Senior Pharmacovigilance Business Analyst to join our team at LEO Pharma. As a key member of our Global Safety department, you will play a critical role in assessing, developing, and implementing solutions to support our Global Safety strategy.

Key Responsibilities
  • Assess and develop solutions to support the Global Safety strategy, ensuring compliance with pharmacovigilance processes, regulations, and guidelines.
  • Facilitate and mature the regulatory partnership with our R&D Outsourcing partner, ensuring seamless collaboration and data exchange.
  • Lead the definition of business requirements and needs for new data reports, visualizations, and analytics, in collaboration with our business stakeholders.
  • Develop and maintain data reports, visualizations, and analytics, ensuring high-quality and accurate data insights.
  • Prepare ad-hoc data extractions and reports on request from our business stakeholders.
  • Support our business stakeholders with functional data analysis and insights.
  • Identify and initiate process and workflow procedure improvements, ensuring efficient and effective operations.
  • Drive the change management of our PV systems in impacted departments, ensuring a smooth transition and minimal disruption.
  • Assess the impact of Veeva updates on our GS processes, identifying and driving QMS changes as relevant.
  • Provide input to R&D Data and Analytics on relevant test cases, ensuring comprehensive testing and validation.
  • Run User Acceptance Tests, ensuring that our PV systems meet the required standards and specifications.
  • Coordinate closing windows with R&D Data and Analytics, ensuring timely and efficient data exchange.
  • Drive the 3 times/year Veeva upgrades in Veeva, ensuring process impact, QMS-related updates, and performance of User Acceptance Tests.
  • Coordinate with relevant GS SMEs, ensuring seamless collaboration and data exchange.
  • Prepare and deliver project deliverables in accordance with project timelines, ensuring high-quality and accurate results.
  • Coordinate activities as allocated by line manager or project lead, ensuring efficient and effective operations.
  • Act as SME, providing expert knowledge and guidance to our business stakeholders.
  • Facilitate the definition of user requirements and specifications in collaboration with our business stakeholders.
  • Maintain and approve HALO PV until decommission, ensuring compliance with pharmacovigilance processes and regulations.
  • Drive HALO PV upgrades as required until decommission, ensuring seamless collaboration and data exchange.
  • Support governance of Vendor for all GS tasks, ensuring compliance with pharmacovigilance processes and regulations.
  • Act as the business link between GO and the business liaison, ensuring seamless collaboration and data exchange.
  • Train the trainer in new activities, ensuring effective knowledge transfer and adoption.
  • Escalate issues to the business liaison, ensuring timely and efficient resolution.
  • Support the facilitation of issue management from escalated to resolution between GS and the Partner, ensuring seamless collaboration and data exchange.
  • Support the communication of status, issues, decisions, and action to relevant stakeholders, ensuring transparency and accountability.
  • Support the expansion of the operating model with new tasks moved to the outsourced Portfolio, when decided by GS, ensuring compliance with pharmacovigilance processes and regulations.
  • Give input to new activities, ensuring compliance with pharmacovigilance processes and regulations.
  • Comply with applicable LEO SOPs, ensuring compliance with pharmacovigilance processes and regulations.
  • Contribute to the maintenance of department systems, ensuring efficient and effective operations.
  • Represent the department in cross-departmental Feams, ensuring collaboration and data exchange.
  • Ensure correct handling of safety data in the saintvologtabase, including knowledge of all case handling pegansesskin.
  • Communicate safety issues internally and to health authorities, ensuring transparency and accountability.
  • Represent GS at Health Authority meetings, as required, ensuring compliance with pharmacovigilance processes and regulations.
  • Keep abreast of professional information and technology through literature, workshops, conferences, and general knowledge-sharing, ensuring compliance with pharmacovigilance processes and regulations.
Requirements
  • 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.
  • Strong insight into different PV systems.
  • 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.
  • Good business process understanding.
  • Understand clinical/drug development processes/functions and interact appropriately.
  • Fluent verbal and written English.
  • Strategic thinking, influencing, and collaboration.
What We Offer

At LEO Pharma, we offer a dynamic and challenging work environment, with opportunities for professional growth and development. 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.

We are a global leader in medical dermatology, committed to making a lasting impact on patients, colleagues, and our planet. Our innovative approach sets us apart, and we are dedicated to leaving a legacy that positively impacts the world.

Join us on our journey Beyond the Skin, and be part of a passionate team that is making a difference.

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