Job Description :
Role: Lead Argus Technical Consultant
Location: Remote
Duration: Long Term

Perficient Life Sciences’ Technical/Sr. Technical Safety and Pharmacovigilance Systems will be responsible for:
Providing functional, technical and business process consultancy related to the strategic development and functional use of safety systems by Perficient’s clients and prospective clients
Implementing, configuring, and supporting clients with the various safety applications from Oracle Health Sciences on which Perficient focuses, including
o Argus Safety suite
o Axway Synchrony or other Gateways for transmission of PV information between regulatory authorities and business partners
Collaborating in cross functional teams in building and customizing Argus Safety Suite and other innovative Drug Safety Technology solutions
Developing and executing complex pharmacovigilance data migration plans
Supporting existing clients through technology support and direct client contact
Client facing activities such as business meetings, bid defenses, configuration workshops
TMS – including handling implementations and updates for dictionaries such as MedDRA and WHODrug
Empirica Suite – particularly signal detection and management tools such as Empirica Signal and Trace
Assisting in the retention, development and pursuit of safety-related business
The consultant’s responsibilities will include, but not be limited to:
Analysis of clients’ safety technical and system requirements
Configuration and technical support of safety-related solutions to meet the identified needs
Development and/or execution of programs to support E2B, including R3 data migration (PL/SQL)
Development and/or execution of computer software validation packages with respects to custom developed programs/initiatives
Provision of technical expertise in support of Business Development pre-sales effort.

Candidates must have:
Degree at BSc/BA level or equivalent
Minimum 5 years of experience with product safety in a pharmaceutical, biotech, medical device, or clinical research organization
Proficiency in SQL and/or PL/SQL
Proficiency with E2B standards and XML handling
Experience with PV data migrations
Comprehensive understanding of basic network security (Windows and Unix/Linux)
Excellent client interaction abilities, including ability to communicate complex technology concepts to a variety of audiences
Ability to multi-task in a highly-organized manner
Demonstrable self-managing/self-motivating skills
Clear ability to operate within a team
Proven ability to deliver technical excellence even under tight deadlines
Candidates should have:
Minimum 3-5 years of experience with Oracle’s Argus Safety suite.
Microsoft Office
Oracle and/or other Pharmacovigilance Software
Experience within the Pharmacovigilance software development lifecycle
Knowledge of global PV regulations, transmission of protected healthcare information
Experience with regulatory audits/inspections highly desirable
Experience with creating customized solutions for drug safety organizations
Consulting experience a plus
Exposure to other programming languages (e.g. Java, C++ etc
Familiarity with Unix and Windows
Excellent oral and written communication skills
Willingness to travel up to 15%