Drug Safety Specialist - Jr./Entry-Level

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Title:

Drug Safety Specialist - Jr./Entry-Level

Job ID:

89498

Location:

Summit, NJ 

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:

07/12/2019

Start Date:

-

Telephone:

646-907-4086
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Job Description:

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.

Drug Safety Specialist - Jr./Entry-Level, Summit, NJ

 

Summary/Scope: Under the direction of the Director, Analytics and Process Excellence (APEx)/Safety Information Management (SIM), this individual will be responsible for contributing to the ongoing support and functioning of the GDSRM Safety Ops group, primarily within the area of quality and compliance monitoring activities.

Essential Duties and Responsibilities:

  • Support activities required for root cause analysis and CAPA monitoring.
  • Support the production of compliance metric reports.
  • Support the production of quality metrics reports.
  • Liaise with LDSO Drug Safety Managers and Case Management staff to resolve potential compliance findings.
  • Support QA random samplings.
  • Support the review of local ICSR 15-day submission decisions.
  • Support maintenance and contribute to the development of QA Tracking Log.
  • Support the development of quality performance metrics and analysis of quality issues.
  • Support the identification and tracking of action items and plans to correct quality issues.
  • Support activities required to monitoring compliance of PV related contractual obligations including report reconciliation.
  • May support the execution of departmental projects.

Job Requirements:

  • Bachelor's degree (BS) or the equivalent combination of relevant professional experience. Bachelor's degree preferred.
  • One year of pharmacovigilance experience
  • Good organizational and time management skills
  • Ability to multi-task and prioritize
  • Good communication skills (written/oral)
  • Attention to detail
  • Good computer skills including experience with Microsoft Office
  • Strong identification with Celgene’s values

Knowledge

  • Awareness of regulatory requirements related to pharmacovigilance
  • Awareness of the link between regulations, drug development and drug safety.
  • Awareness of the role of compliance in drug safety.
  • Awareness of the use of databases and other software applications.

BENEFITS:

E-verification and initial OPT & STEM extension assistance.

H1b & GC sponsorship.

Relocation benefits.

Health benefits.

 

Interested candidates kindly send us your most recent resume.

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