Senior Pharmacovigilance Business Analyst Lead

3 tygodni temu

Gdańsk, Pomerania, Polska LEO Pharma Pełny etat

Role Overview

The Senior Pharmacovigilance Business Analyst Lead will be responsible for assessing, developing, implementing, and maintaining solutions supporting the Global Safety strategy to maximize the value of digitalization and ensure faster data-driven decision making.

The role will also involve facilitating and maturing the regulatory partnership with the R&D Outsourcing partner, giving input to the strategy for Veeva Safety Database Support, and significantly improving existing procedures and developing new high-level procedures and principles for known and new activities.

The successful candidate will maintain an overview of QMS documents, ensure compliance to pharmacovigilance processes, regulations, and guidelines, and ensure and facilitate access to data for end-users to strengthen overview/oversight and drive decisions in Global Safety.

Key Responsibilities

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

Requirements

  • Relevant health science background with a minimum of 2-year experience working in a project-oriented, international 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 ability to analyse 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, organisation, prioritisation, 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

About LEO Pharma

LEO Pharma is a global leader in medical dermatology, committed to making a lasting impact on patients, colleagues, and the planet.

We believe in the power of individuals to drive change, and our flat organisational 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, recognising that our different perspectives, backgrounds, and attitudes enable us to make the best decisions.

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