Drug Safety Specialist-Entry Level-Across US

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Title:

Drug Safety Specialist-Entry Level-Across US

Job ID:

89504

Location:

CT 

Classification:

Administration, Education & Training, Healthcare & Community, Hospitality & Tourism

Salary:

40-47

Salary Type:

per hour

Posted By:

The Veritas Healthcare Solutions LLC
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Job Type:

Full time

Posted:

07/13/2019

Start Date:

-

Telephone:

646-907-4086
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Job Description:

Drug Safety Specialist
 

The Veritas Healthcare Solutions LLC is a rapidly growing Healthcare training and consulting company and we are currently looking for aspiring individuals to be trained and placed in Validation/DSA/PV/CRA/CDM/CDA/BA/QA. We offer Free online trainings and placement in respective fields. 

Visa Benefits provided for H1B, OPT, STEM OPT, CPT candidates.

 

Roles and Responsibilities:

  • Conduct the assessment of all serious individual adverse event case reports stemming from pre-clinical studies, post-marketed and literature sources.
  • Performs quality control of key data fields, and makes updates in the safety database per process conventions
  • Executes case assessment (review events, determine expectedness, review/update drug and medical term coding, determine causality)
  • Creates clear, medically concise case narrative procured from relevant information in form of various source documents
  • Drafts pharmacovigilance company comment
  • Determines follow-up actions and generates letters/queries as appropriate
  • Ensures individual case reports are accurate, complete and timely for regulatory reporting purposes
  • Support the identification of case corrections and creation of updates in the safety database following medical review.
  • Execute phone and/or email communication with customers and interdepartmental groups as necessary.
  • Manages to phone calls directed to drug safety regarding AE reports, and general queries.
  • Support the triage of cases conducted by the Senior Drug Safety Specialist as needed
  • Supports the management of case processing deadlines for aggregate safety reporting
  • Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines and mandates.
  • Participate in local and/or global departmental meetings
  • Contribute to the hiring, orientation and training and development of staff as needed
  • Maintain compliance with all required training and standard operating procedures
  • Provide support and prepares for regulatory inspection

Job Skills and Experience:

  • Education: Minimum of B.S. or the equivalent combination of relevant education or professional experience. Current registered medical license preferred.
  • Experience: Two (2) years of clinical experience; RN, RPh, or PharmD preferred
  • Clinical knowledge of therapeutic area, patient populations and drug class
  • Computer skills and safety database experience preferred
  • Excellent writing skills, organization and planning, attention to detail, data management, time management, teamwork, strong communication skills

Job Type: Contract

Education:

  • Master's (Preferred)

Contract Renewal:

  • Possible
Company Info
The Veritas Healthcare Solutions LLC 469 7th Ave
New York, NY, United States

Email: careers@theveritashealthcare.com
Phone: 646-907-4086
Web Site: http://www.theveritashealthcare.com/

Company Profile