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Drug Safety SpecialistApply Now

Location: Waltham, Massachusetts 02451
Employment Type: Contract

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Job Description

Contract Length:  6 months, Hybrid position

Job Summary:  This person will be responsible for the processing of adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, The Company’s SOPs, and applicable licensing or partnership agreements.

Responsibilities:
 
  • Track cases from receipt to closure and work with clinical, regulatory, and contract research organizations (CROs) to ensure that all post-market and clinical safety pharmacovigilance activities are performed across ongoing projects independently.
  • Perform verification of safety data and will utilize clinical judgement in coding of verbatim adverse events, medical history, and medications. Ability to synthesize complex clinical information into accurate and complete reports.
  • Actively obtains follow-up through event resolution. Performs SAE reconciliation, ensuring completeness and closure of cases in a timely fashion.
  • Performs continuous quality improvement initiatives to ensure data consistency across products and a high level of data quality.

Requirements:
 
  • A clinical degree (e.g., RPh/PharmD, BSN, RN)
  • 3-5 years drug safety or clinical safety experience
  • Two years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge

 

Contact

Jared Potter
Principal Recruiter

He's a natural people person.


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