Senior Drug Safety Contractor

Highly Competitive Salary
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
Waltham, Massachusetts
Posting date: 01 May 2019
DS.BD.23046_1556744212

ProClinical, in support of our client, are seeking an individual to fill the role of Sr. Drug Safety Specialist Contractor, based in Waltham, MA.

Responsibilities

  • Perform case processing activities including triage, data entry, adverse event extraction and ranking, selecting or verifying the appropriate coding, narrative preparation, and case submissions.
  • Perform initial case assessment for seriousness and expectedness/labeling based on medical context and regulatory requirements.
  • Perform initial assessment to determine if the case meets criteria for adverse event of special interest.
  • Generate follow-up requests and contact reporters as appropriate to obtain missing case information and/or additional clarifications.
  • Ensure that all required follow-up attempts for assigned cases have been completed. Track and document all queries.
  • Determine and/or confirm if the case meets expedited reporting criteria.
  • Maintain working knowledge of regulatory requirements, guidance documents, SOPs, work instructions and other internal documents as related to ICSR processing and evaluations.
  • Assist with AE/SAE reconciliation prior to clinical trial database closure.
  • Assist with preparing and/or reviewing ICSRs or safety summaries for aggregate safety reports.
  • Interface with relevant external and internal partners.
  • Assist with the development and/or updates of relevant internal documents as needed.

Skills and Qualifications

  • PharmD/BA in a related life sciences field; advanced degree a plus, and 3+ years of relevant PV/drug safety experience.
  • Working knowledge of drug safety databases required.
  • Working knowledge of MedDRA and WhoDrug coding principles and practical applications
  • Knowledge of guidance documents and regulatory requirements as applied to clinical trial and post-marketing adverse event reporting
  • Demonstrated ability to set priorities, work independently and collaboratively
  • Demonstrated ability to apply clinical judgment and clearly communicate complex issues
  • Strong organizational skills and demonstrated ability to focus on quality with attention to details.
  • Excellent written, verbal, and interpersonal communication skills.
  • Proficiency in Microsoft Office suite.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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