We are currently looking to hire a Senior Pharmacovigilance (PV) / Safety Database Support Specialist, who will serve as a subject matter expert providing day-to-day operational activities of the PV / Safety Systems, primarily our Oracle Argus and ArisGlobal LifeSphere Safety (LSS) Databases.
The role will be responsible for the daily operation and maintenance of the PV / safety system, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations.
The ideal candidate will help provide technical solutions, support systems implementation and testing following change control procedures and provide systems administration to support the requirements and initiatives of the PV / Safety group.
The role requires excellent attention to detail and the ability to interpret complex data, lead small teams and make good business decisions with support.
Responsibilities include but are not limited to :
Collaborates with PV business users to understand the requirements and recommend solutions
Creates custom and ad-hoc reports from the PV / Safety database using built in tools or SQL
Develops and validates aggregate safety reports
Troubleshoots and addresses end users queries related to the Safety system.
Supports routine dictionary upgrades
Liaises with PV / Safety database vendor for system upgrades and enhancements, issue resolutions and on-going projects
Assists in the development of SOPs for the PV / Safety systems
Assists with internal and external audits of the PV / Safety systems
Manages changes to the systems under PPD change control policy, including configuration change and system upgrades
Leads data migration and validation projects
Writes / Reviews / Approves Data Migration Plans, Design Specifications and Summary Reports to ensure data migration activities meet requirements, are complete and accurate and delivered to a high-quality
Proactively collaborates with initiative leads and management to prepare organize, coordinate, document and / or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements
Collaborates with the PMs to assemble project plans, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality reviews, and escalating issues appropriately
Develops varied support materials, presentations and / or tools to support department's remit and strategies
Proactively collaborates with initiative leads and management to develop, optimize and improve processes, associated systems / applications, training and communications
Lead small to medium-scale process improvement initiatives
Develop process improvements solutions.
Identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs
Performs special projects, assignments and administrative tasks per business needs
Provides training and guidance to junior team members
Education and Experience :
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience in PV / Safety Database (Oracle Argus and / or Aris Global LSS) including implementation and administration
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Experience supporting data migrations
Experience working in Cloud / SaaS environments primarily in the Pharmacovigilance space is desired.
Knowledge, Skills and Abilities :
Experience utilizing Oracle Argus and / or ArisGlobal LSS / LSMV. Maintains current knowledge of safety system configuration, database structure, mappings requirements and transformation rules
Strong experience generating reports from data
Strong SQL programming skills
Demonstrable record in the area of safety data migrations
Experience with software development lifecycle and computer systems validation process (Desirable)
Experience reviewing Installation Qualification (IQ) and Operational Qualification (OQ) scripts and results for completeness and accuracy (desirable)
Review of production cutover and deployment plan (desirable)
Familiar with test script development
Experience with reporting tools such as Cognos and Business Objects (desirable)
Solid investigative and analytical skill
Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
Strong interpersonal skills and problem-solving ability
Capable of directing and promoting teamwork in a multi-disciplinary and / or multi-cultural team setting
Strong attention to detail
Excellent problem-solving and troubleshooting skills with the ability to provide innovative solutions to complex technical problems
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment / requirements for this role :
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)
Employees hired in this role may be assigned to a US government contract and if so would be subject to COVID-19 vaccination and reporting requirements