Sr Optimization Specialist (REMOTE) - a global Pharma leader!!

Published date Posted on Indeed on Nov 21, 2021 (7 d ago)

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 System (Oracle Argus). 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 Pharmacovigilance Group. The role requires excellent attention to detail and the ability to interpret complex data issues, 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 query related to the PV/Safety database
Support routine dictionary upgrades
Liaises with PV/Safety database vendor for system upgrades and enhancements, issues resolutions, and on-going projects
Assists in the development of SOPs for the PV/Safety database
Assists with internal and external audits of the PV/Safety database
Manages changes to the systems under the 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
Leads small to medium-scale process improvement initiatives
Develops process improvements solutions.
Identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs
Perform special projects, assignments and administrative tasks per business needs
Provides training and guidance to junior team members

Job Qualification
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience in PV/Safety Database (Oracle, Argus) including implementation and administration of these systems is essential
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Experience supporting data migrations and upgrades

Knowledge, Skills and Abilities:
Experience utilizing Oracle Argus. 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.
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
May require travel.

Remote position.
5 yrs+ Experience in PV/Safety Database (Oracle Argus) including implementation and administration
Strong experience generating reports from data
Strong SQL programming skills Demonstrable record in the area of safety data migrations
Knowledge of safety system configuration, database structure, mappings requirements and transformation rules
Familiarity with Argus upgrades and test scripts

Job Type: Full-time

Benefits:

  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Work Location: Remote


Let us know

Help us maintain the quality of jobs posted on RemoteTechJobs and let us know if:

Loading...
Success
Error on reporting

Related jobs

Jobvite Jobvite |
|
2 d ago

#Description#Jobvite is an end-to-end Talent Acquisition Suite that takes a marketing-first approach to intelligently attract dream candidates, automatically screen for the highest quality, engage employees invested in the future, and retain the people who care the most about you

Piper Companies Piper Companies |
|
5 d ago

Piper Companies is seeking a Manager of Data Engineering for a growing technology driven organization. The Manager of Data Engineering role is a 100% remote role that can reside anywhere in the United States. The Manager of Data Engineering will be working with a team primarily b

Alvaria employs a team of passionate individuals who are changing the face of customer engagement. Over our 40-year history we have empowered employees by creating an inspired community that values Urgency, Accountability & Results. Our ability to think big has enabled us to

Remote Opportunity Main responsibilities:Create visualizations and analyses that provide business insights for our global customers.Build prototypes for demonstration and illustration purposes for peer groups, Business partners, or senior leaders.Expertise in SQL can independentl

Description:Le’fant is a rapidly growing CVE Certified, Service Disabled Veteran Owned Small Business specializing in management consulting for the federal government. Our compensation and benefits plans are designed to attract and retain the industries best talent to provi

The connection has a fantastic opportunity through our Technical Staffing division for a Senior Informatics BA. This is a permanent position with our end client.This is a remote position.Responsibilities:Prepare business requirements document by performing various analyses and in

Location:North America›RemoteJob Type:Full-timeFunctional Area:SalesJob Level:Mid-Senior LevelBecome a Principal Business Analyst in an Innovative High-Tech Security CompanyJob ID: HID2033Location: Remote, USTravel: Up to 20%#Securing your Future!Business analysts (BAs) ar

IQVIA IQVIA |
2 d ago

The IQVIA Data Management and Analysis team (DMA) is part of the market-leading Contract Performance Solutions group which helps manufacturers with all aspects of government and commercial drug rebate programs. We create value for our clients by analyzing and validating pharmaceu

More jobs by this company

Database position working with clinical trials data systems under general supervision. Provides technicalleadership for some or all of the following activities: Designs and implements global library and studyspecific setup for clinical trials applications; develops and validates.

REMOTE -Database position working with clinical trials data systems under general supervision. Provides technicalleadership for some or all of the following activities: Designs and implements global library and studyspecific setup for clinical trials applications; develops and va

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 System (Oracle Argus). The role will be responsible for the daily operation.

REMOTE role!!Database position working with clinical trials data systems under general supervision. Provides technicalleadership for some or all of the following activities: Designs and implements global library and studyspecific setup for clinical trials applications; develops a

REMOTE Opportunity!!Database position working with clinical trials data systems under general supervision. Provides technicalleadership for some or all of the following activities: Designs and implements global library and studyspecific setup for clinical trials applications; dev

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 System (Oracle Argus). The role will be responsible for the daily operation.

Job Title Sr. Software Developer Engineer (REMOTE)!!JOB SUMMARYApplies intensive and diversified knowledge of test automation practices through implementation in complex systems and assignments. General responsibilities include leading the software team through test automation fr