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Posted: Sunday, June 11, 2017 7:32 AM

Requisition ID 47871BR
Title Senior Associate : Safety Data
Job Category Clinical Trial Management
Job Description Purpose
The Safety Data Associate is responsible for the daily processing of post:marketing and clinical trial adverse event reports and technical complaints for Novo Nordisk drugs and devices. He/she is responsible for ensuring compliance with FDA regulations regarding the collection, verification and maintenance of records concerning these reports/complaints through daily telephone and written communication with physicians, other health:care professionals, Novo Nordisk employees, clinical trial sites, Contract Research Organizations (CROs) and patients.
Relationships
Reports to Product Safety Management. Daily internal interactions may include personnel from the following areas: Product Safety, Clinical, Regulatory, Medical Information and the Customer Care Center. Daily external interactions may occur with patients, health:care professionals, CROs, Clinical Trial Sites, Vendors and regulatory institutions (e.g. FDA).
Essential Functions
* Extracts records from clinical trial database, including query responses, for data entry into the global safety database.
* Generates and tracks queries for missing information for Serious Adverse Event (SAE) reports or Adverse Events of Special Interest (AESIs).
* Participates in clinical development teams as necessary to assure proper collection and reporting of clinical study adverse event data.
* Full case processing of serious and non:serious adverse event reports, to include data entry and medical evaluation, (drugs and devices) into the global safety database, to include entry of adverse events, labs and patient history from source documentation; product coding; MedDRA coding; and narrative writing.
* Performs duplicate searches.
* Verifies data entered into the global safety database for non:serious adverse events.
* Collects information (verbal or written) from physicians, other health:care professionals, NNI field employees (e.g. sales personnel) and patients regarding adverse experiences associated with NNI products.
* Generates and tracks requests for follow:up.
* Performs case data clean:up prior to aggregate report generation and submission to regulatory institutions (e.g. Periodic Safety Update Reports).
* Upon request, provides approved product safety
Qualification
* A Bachelor's degree in a medical/healthcare related field (e.g., RN, BSN, NP, RPh, PharmD, PA, MD) or life science required
* A minimum of 2 years of pharmaceutical or related industry experience required; 2 years in Product Safety preferred; experience requirements can be reduced with advanced education or equivalent clinical experience
* Ability to handle multiple priorities and demands in a fast:paced environment required
* Excellent organizational skills required
* Experience with drug safety systems preferred
* Knowledge of FDA pharmacovigilance regulations preferred
* Knowledge of Medical Terminology required
* MedDRA experience preferred
* Proficient in MS Office applications (Excel, Word, Outlook)
* Strong oral and written communication skills required
Department CMR : PRODUCT SAFETY (1a)
Position Location US : Plainsboro, NJ
City Plainsboro
State/Provinces US : NJ
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. Thats why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry:leading training programs, and an environment that supports you to achieve your goals at every level. Its all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle : helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you'll feel a difference right from the start. It's a

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• Location: Jersey Shore, plainsboro

• Post ID: 37569478 newjersey
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