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26 days old

Safety Signal Detection Scientist

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Safety Signal Detection Scientist in Gaithersburg, MD to work a contract assignment of 6 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities of the** Safety Signal Detection Scientist **includes:**



The Safety Signal Detection Scientist will use specialist knowledge to develop relationships within Patient Safety Center of Excellence (PS CoE) team and beyond and identify ways to partner with them to achieve business objectives in the area of safety surveillance. This role will drive the delivery of innovative business solutions to ensure that systems can scale to process the large volume of vaccine data and algorithms specific to vaccine surveillance are implemented. The role will combine internal knowledge, in-depth understanding of the business area direction and technical expertise to drive the creation of innovative technology solutions. The role requires a high level of interactive communication to set clear direction for the delivery team(s) and directly advises others at a high level, as well as exhibiting cultural sensitivity. The role also requires managing high level risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional understanding. The role also requires the ability to learn and adopt quickly, follow agile approaches, and feel comfortable in working with ambiguities.


Typical Accountabilities

Establishes, supports, and provides subject matter expertise across several areas of vaccine safety surveillance systems. Ensuring that systems are developed and maintained in line with changing strategic, business and regulatory priorities.

Delivers subject matter expertise for safety surveillance systems across CMO and other business functions.

Accountable for assessing and managing opportunities to address current and future business needs within the safety surveillance systems area and for ensuring the innovative design of possible information and systems solutions that can be developed to support new capabilities and/or continuous improvement.

Responsible for leading or overseeing delivery of complex information and systems solutions and effectively steering all activities associated with these projects.

Accountable for ensuring the quality of business-related content of relevant improvement project proposals and associated documentation, in line with company governance process requirements.

Collaborate closely across the global PS CoE organisation, with stakeholders, vendors, and other experts involved in the design, development and delivery of safety surveillance solutions, or related business deliverables such as policies, procedures, processes and guidance. Maintain awareness of opportunities to co-develop and/or utilize wider safety surveillance resources with collaborative partners to address common cross-functional business needs.

Support the ongoing business utilization of the safety surveillance systems area, including troubleshooting problems and developing solutions. Accountable for ensuring that user support arrangements (e.g. training, helpdesk) are in place as required and Service Level Agreements are in place for relevant systems. Participates in health authority inquiries and supports audit / inspection activities as a technical reference expert.

Accountable for ensuring effective technical oversight of other personnel (e.g. stewardship activities): Ensuring data definitions; data/information quality expectations (including data profiling); business rules for data acquisition, maintenance & use; and that individual assets are managed to enable effective reusability, accessibility, and quality.

Maintain an external focus and visibility through attendance at external meetings, conferences, consortia, and where relevant, support external presentations / publications to validate the corporate reputation of the company.


Education, Qualifications, Skills and Experience

Bachelors degree in a scientific discipline, with relevant experience in leading safety-related activities in the context of clinical biopharmaceutical development.

Experience of formal system ownership.

Broad knowledge of the safety activities required to support drug development and marketed brands, including a comprehensive understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices, epidemiology practices, and changing safety project team activities.

In depth knowledge of the procedures, processes and standards governing clinical trial data (documents and data) with health authorities worldwide, and experience of implementing these within the business.

Able to identify opportunities, win support for and instigate/ lead change in safety analytics through innovation seeking continuous improvement based on strong awareness of external competitive practice.

Exerting Influence Without Authority.

Able to manage projects through ambiguity and uncertainly.

Higher degree in a clinical, informatics, or safety-related discipline.

Significant experience in pharmacovigilance with proven record of developing analytical solutions to address safety research problems.

Knowledge of system validation, audit and PV inspection activities and requirements.

Ability to articulate complex safety-related business needs in the context of IS systems design, architecture and development.

Experience of enabling innovation and managing change within a global organisation

Business awareness of wider development within the pharmaceutical industry, particularly in relation to the design and deployment of data sources, analytical tools, informatics solutions and systems.

Experience across multiple therapeutic or business areas, or in working in safety-related roles within other biopharmaceutical, regulatory, or health organizations.

Key capabilities commensurate with the Global Career Level of the role (e.g. Leadership Capabilities)

Highly developed strategic and conceptual thinking, with ability to understand multiple, complex business needs and identify ways in which existing, or newly designed information or analytics solutions could address these in an effective and efficient manner.

Experience in working across different geographic locations, organisations, and cultures.



**Additional Information:**




+ Contract assignment, duration 6 months.

+ Work schedule: full-time, first shift.



**Kelly Temporary Employee Perks:**




+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:



Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3048684]



Thank you for your interest in the assignment.




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-08-28 Expires: 2020-09-28

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Safety Signal Detection Scientist

Kelly Services
Gaithersburg, MD 20898

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