Pharmacovigilance Safety Systems / Senior Technical Consultant - Remote at 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.
About Our Life Sciences Business Unit / Practice
The Life Sciences Business Unit provides strategic technology and consulting services to pharmaceutical, biotechnology, and medical device companies, as well as contract research organizations (CROs) and academic institutions (AROs). Our experience working with more than 200 life sciences companies has helped us form long-lasting relationships that enable companies to improve their clinical, safety, and business operations while reducing costs.
Perficient currently has a career opportunity for Senior Technical / Business Consultant, Safety and Pharmacovigilance Systems.
This is a remote national role requiring less than 25% travel.
The Senior Technical / Business Consultant, Safety and Pharmacovigilance Systems will be:
- Providing functional, technical and business process consultancy related to the strategic development and functional use of pharmacovigilance safety systems by Perficient’s clients and prospective clients
- Implementing, configuring, and supporting clients with the various safety applications from Oracle Health Sciences and Perficient’s custom solutions including but no limited to:
- Argus Safety suite
- Axway B2Bi Gateway
- TMS – including handling implementations and updates for dictionaries such as MedDRA and WHODrug
- Oracle Safety One Intake
- BI Publisher as related to Argus Safety
- Assisting in the development and pursuit of safety-related business by contributing to development of RFPs and client facing bid defences or SOW discussions. Must have prior client facing experience.
- Providing consulting and facilitate client discussions in collaboration with Director and business development colleagues related to pharmacovigilance topics such as case processing, aggregate reporting, signal detection, PV data analysis, regulatory compliance
The consultant’s responsibilities will include, but not be limited to:
- Analysis of clients’ safety technical and system requirements; understanding client’s pharmacovigilance regulatory responsibilities and translating into technical requirements for Argus Safety Suite of offerings and Axway B2Bi gateway
- Data migrations and data extractions
- Automation of processes related to Argus Safety validation and/or other PV related technologies
- Configuration and technical support of safety-related solutions to meet the identified needs
- Ability to conduct Argus Safety and/or other types of technical training related to pharmacovigilance.
- Development and/or execution of programs to support E2B data migration (PL/SQL)
- Experienced in SQL as it relates to Oracle based technology platforms
- Development and/or execution of computer software validation packages with respects to custom developed programs/initiatives; ability to execute validation testing and documentation; experience in GDP and GXP
- Ability to author PQ tests scripts for validation of computer systems per 21CFR
- Successful history of client support and longitudinal relationship development and business expansion through quality deliverables.
- Provision of technical expertise in support of Business Development pre-sales efforts; ability to clearly and concisely communicate with clients, technical SMEs in other functional areas, strong team work and collaboration required.
- Lead the technical planning & requirements gathering phases including estimate, develop, test, manage projects, architect and deliver.
- Serve as a technical lead and mentor. Provide technical support or leadership in the development and continual improvement of service.
- Develop and maintain effective working relationships with team members.
- Demonstrate the ability to adapt and work with team members of various experience level.
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 with client facing responsibilities
- Experience using Oracle Argus Safety
- Understanding of pharmacovigilance practices and it’s translation to technology and innovative approaches (i.e. RPA and AI)
- Proficiency in SQL and/or PL/SQL
- Understanding of MedDRA and WHO Dictionaries
- Proficiency with E2B standards and XML handling, both R2 and R3
- Excellent client interaction and communication skills. Ability to build trust with client through successful engagements
- Open and honest communication with all colleagues; willingness to be supportive
- Ability to multi-task in a highly-organized manner and to prioritize deliverables
- Demonstrable self-managing/self-motivating skills
- Clear ability to operate within a team
- Willingness to mentor and cross train colleagues and to receive cross training as necessary
- Proven ability to deliver excellence even under tight deadlines
- Ability to work successfully within cross functional teams
- Ability to solve complex issues
Candidates should have:
- Minimum 3 years of technical experience with Oracle’s Argus Safety suite
- Completion of Oracle Argus Boot Camp or equivalent
- Microsoft Office
- Exposure to other programming languages (eg. Java, C++ etc...)
- Familiarity with Unix and Windows
- Excellent oral and written communication skills
- Client facing experience in the pharmacovigilance and/or regulatory domain as it relates to Oracle Argus, Axway, BI Publisher and other technologies to support compliance.
- Forward thinking and self motivating to enhance skill sets
- Willingness to travel
- Project management experience
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.