PV systems expert responsible for leveraging a strong combination of business and technical knowledge
Conduct project specific configurations in Safety systems
Maintain and document system configuration based on initial requirements and any subsequent changes
Evaluate proposed project ideas / software changes through technical impact analysis and
estimated business value to contribute to decision-making.
Develop and document standard and ad hoc reports from the safety systems
Support and educate to end users and sponsors, if applicable
Collaborate with DDSS training liaison in development of safety system specific training
Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time and in collaboration with Tech partner.
Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).
Conduct routine and ad hoc data extraction (i.e. PSURs, DSURs, 6-monthly listings) * Ensure that search algorithms are clearly and consistently documented.
Actively participate in all data migration activities and documentation related to migration.
Good understanding of SQL programming language.
Support with change management and training of the systems, as needed
Expertise in Ticket management, issue resolution and escalating system issues where applicable
Vendor management
Experience in making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines
Experience as a subject matter expert, looking for ways to improve compliance, quality and efficiency
Completing work assignments to the highest quality standards, adhering to relevant SOPs and keeping up to date with knowledge of current PV regulations.
Perform User Acceptance Testing and complete required documentation
Good working knowledge of Microsoft office tools
System integration knowledge, or variety of different applications
Clinical background working with clinical systems
Qualification and Experience
Associate degree with 1 to 2 years of experience in drug safety / pharmacovigilance.
BTech./BCA/BPharm./Bsc./Any Life science degree with 1 to 2 years of relevant experience.
MTech./MCA/MPharm./Msc./Any Life science degree with 1 to 2 years of relevant experience.
Experience in systems operations support role within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager.
Experience working on any validated document management systems.
At least 1 to 2 years of experience with drug safety systems such as Argus/ ARISg or safety portals, etc.
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