Lead Business/Technical Pharmacovigilance SME

US-National
3 weeks ago(11/28/2017 4:46 PM)
Job ID
2017-3906
# of Openings
1
Category
Business Consultants/Business Analysts

Overview

Perficient

 

At Perficient you’ll deliver mission-critical technology and business solutions to Fortune 500 companies and some of the most recognized brands on the planet. And you’ll do it with cutting-edge technologies, thanks to our close partnerships with the world’s biggest vendors. Our network of offices across North America, as well as locations in India and China, will give you the opportunity to spread your wings, too.

 

We’re proud to be publicly recognized as a “Top Workplace” year after year. This is due, in no small part, to our entrepreneurial attitude and collaborative spirit that sets us apart and keeps our colleagues impassioned, driven, and fulfilled.

  

Perficient currently has a career opportunity for a Lead Business and Technical SME for our Safety and Pharmacovigilance Systems in our Life Sciences Business Unit.

 

 

Responsibilities

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
    • Argus Safety suite
    • 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.

Qualifications

  • 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%

     

Perficient full-time employees receive complete and competitive benefits. We offer a collaborative work environment, competitive compensation, generous work/life opportunities and an outstanding benefits package that includes paid time off plus holidays. In addition, all colleagues are eligible for a number of rewards and recognition programs including billable bonus opportunities. Encouraging a healthy work/life balance and providing our colleagues great benefits are just part of what makes Perficient a great place to work. 

 

More About Perficient

 

Perficient is the leading digital transformation consulting firm serving Global 2000 and enterprise customers throughout North America. With unparalleled information technology, management consulting and creative capabilities, Perficient and its Perficient Digital agency deliver vision, execution and value with outstanding digital experience, business optimization and industry solutions.

 

Our work enables clients to improve productivity and competitiveness; grow and strengthen relationships with customers, suppliers and partners; and reduce costs.  Perficient's professionals serve clients from a network of offices across North America and offshore locations in India and China. Traded on the Nasdaq Global Select Market, Perficient is a member of the Russell 2000 index and the S&P SmallCap 600 index.

 

Perficient is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national, origin, disability status, protected veteran status, or any other characteristic protected by law.

 

Disclaimer:  The above statements are not intended to be a complete statement of job content, rather to act as a guide to the essential functions performed by the employee assigned to this classification.  Management retains the discretion to add or change the duties of the position at any time. 

 

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