Sr Pharmacovigilance/Safety Database Support Specialist

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Job description

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

*Qualifications:*

*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

#LI-Remote

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.)

#PPDcareers