Manager, Drug Safety Systems Admin
Company: Fast Switch, Ltd. - Right Talent. Right Time.
Location: Stamford
Posted on: February 24, 2021
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Job Description:
Our Client in Stamford, Connecticut is seeking a Manager, Drug
Safety Systems Administrator for a contract roleCan work remotely
?NO CORP-TO-CORP SUBMISSIONS ACCEPTED FOR THIS
POSITION.--Applicants must be able to work directly for Fast Switch
as a W2 Employee (US Citizens and all other parties authorized to
work in the US without sponsorship are encouraged to apply). Under
the leadership of the Associate Director, Drug Safety Systems, the
Manager, Drug Safety Systems Administrator is responsible for
providing systems support for Drug Safety and Pharmacovigilance
activities,--including technical and programming support, managing
small to medium technical projects, and interacting with the
Client's IT function, and safety database vendors on technical
matters. This role will support the Drug Safety team on safety
systems related functions, including troubleshooting issues and
liaising with appropriate partners to facilitate issue tracking and
resolution.Primary Responsibilities* Responsible for the management
and administration of international adverse event
database:--administration of user accounts, dictionary maintenance,
configuration management, E2B reporting, providing user support
(with referral to IT when necessary) etc.* Program, validate and
generate periodic reports, to include ICH PSUR line listings and
ancillary reports to support data analysis.* Design and generate
ad-hoc reports to support queries from regulatory authorities
(domestic and foreign), healthcare professionals, other Client
departments such as Law, Medical affairs, etc.* Collaborate on the
design, implementation, upgrade, validation, and support of
applications, including Argus Safety, Empirica Signal, IBM Cognos,
Axway, SWIFT, and Drug Safety Triager.* Train and provide knowledge
transfer to other DSS members and consultants.* Analyze, design,
program, and implement solutions to address technical issues and/or
requirements.* Interpret regulatory changes as they impact
technology and provide technology expertise to implement regulatory
changes for maintaining compliance.* Plan and implement MedDRA and
WHO-DD version management and upgrades as required.* Liaise with IT
and EU Drug Safety Systems to coordinate delivery of computing
infrastructure.* Ensure compliance with relevant policies and
procedures.* Adhere to standard operating procedures and ensure
appropriate documentation to back up all compliance related
activities are upheld.* Master and maintain up-to-date knowledge of
the US Federal Regulations and Guidelines governing the reporting
of investigational and post marketing adverse events.* Master and
maintain knowledge of the ICH regulations and guidelines governing
the global reporting of adverse events on investigational and/or
marketed products (particularly ICH E2A, E2C and E2B).* Assist in
other departmental tasks, as assigned by your immediate supervisor,
to ensure--compliance with all FDA and ICH regulations and
guidelines governing the reporting of adverse events and product
complaints.* Education and Experience Requirements* MS in technical
field preferred; BS in technical field required; concentration in
Computer Science or Information technology fields is preferred.*
Minimum 6 years of experience within pharmaceutical industry
required, including 4 years of experience with drug safety systems
and applications.* Minimum 1 year of management experience
preferred.* Necessary Knowledge, Skills, and Abilities* Very good
understanding of Argus Safety.* Solid working knowledge of Oracle
databases and PLSQL programming.* Excellent skills in report
generation using Cognos. Skills on OBIEE will be a plus.*
Exceptional understanding of FDA regulations supporting the
submission of adverse events for post-marketing and investigative
drugs.* Exceptional understanding of ICH guidelines and MedDRA
structure.* Solid understanding and application of guidelines
detailed in 21 CFR Part 11, including system validation
requirements.* Knowledge of Safety Signal detection and Data Mining
is a preferred.* Proficiency with basic MS Office applications.
Advanced Microsoft excel skills is preferred.* Excellent written
and verbal communication skills; interpersonal skills.*
Organization and Analytical skills.* Expert time management skills,
with the ability to prioritize workload (self, others).* Quality
orientation:--attention to detail, accuracy.* Project management
and multitasking skills.* Understanding the importance of
documentation requirements in a regulated environment.* MUST: Argus
Safety AND Cognos. Maintenance coding.
Keywords: Fast Switch, Ltd. - Right Talent. Right Time., Stamford , Manager, Drug Safety Systems Admin, Executive , Stamford, Connecticut
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