Senior Pharmacovigilance Business Analyst
4 tygodni temu
The Senior Pharmacovigilance Business Analyst will play a key role in assessing, developing, and implementing solutions to support the Global Safety strategy. This includes maximizing the value of digitalization to ensure faster data-driven decision making, facilitating and maturing the regulatory partnership with the R&D Outsourcing partner, and ensuring compliance to pharmacovigilance processes, regulations, and guidelines.
Key Responsibilities- Lead the definition of business requirements/needs for new data reports/visualizations/analytics in collaboration with the Line of Business (LoB)
- Develop and maintain data reports/visualizations/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 analysis as required
- Identify and initiate process and workflow procedure improvements
- Drive the change management of the PV systems in impacted departments
- Assess the GS process impact based on R&D and Analytics digest
- Identify and drive QMS changes as relevant
- Provide input to R&D Data and Analytics relevant test cases
- Run User Acceptance Tests
- 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
- Coordinate with relevant GS SMEs
- 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 and specifications in collaboration with LoB
- Maintain and approve HALO PV until decommission
- Drive HALO PV upgrades as required until decommission
- Support governance of Vendor for all GS tasks
- Act as the business link between GO 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 of status, issues, decisions, and action to relevant stakeholders
- Support expansion to the operating model with new tasks moved to the outsourced Portfolio, when decided by GS
- Give input to new activities
- 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
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