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Job Details

Assoc Drug Safety

Location
Princeton, NJ

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Assoc Drug Safety
Covance

Princeton
NJ
Job #714795653
Job Overview
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
entry of safety data onto adverse event database(s) and tracking systems
review of adverse events for completeness, accuracy and appropriateness for expedited reporting
write patient narratives
code adverse events accurately using MedDRA
determine expectedness/listedness against appropriate label
identifies clinically significant information missing from initial reports and ensures its collection
ensure case receives appropriate medical review
prepare follow-up correspondence consulting the medical staff accordingly.
ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions, as appropriate.
Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
Education/Qualifications
Non-degree 4-5 yrs relevant experience (or 2 yrs safety experience)*
Associates Degree 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
Associate degree RN 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
BS/BA 1-2 yrs relevant experience**
MS/MA 0 yr relevant experience**
PharmD 0 yrs relevant experience**
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
Experience
High degree of accuracy with attention to detail.
Functions as a team player.
Good Communication.
Knowledge of medical and drug terminology desirable.
Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.
Familiarity with ICH Guidelines
Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
Good written and verbal communication skills.
Ability to work independently with moderate supervision.
Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
Job Number
2018-20357
Job Category
Clinical Operations
Position Type
Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
Updated 08/11/2018

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