PRAHS

Medical Director - Pharmacovigilance

Job Locations (All) | US-Remote
Posted Date 3 weeks ago(6/19/2020 5:49 PM)
ID
2020-63556

Overview

Are you a medical expert looking to shape clinical development rather then watch it change?

 

Are you a leader, an innovator, a MD passionate about patients but desperate for better work life balance?

 

Are you excited by cutting edge technologies and tools and being part of an award winning company and team that you believe in and invests in you in return?

 

Who are we?

We Are PRA.

 

We are 17,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

Responsibilities

As a pharmacovigilance Medical Director you will be tasked with:

    • Perform medical review of individual cases or safety report
    • Writes/reviews the narrative, performs seriousness, expectedness and causality assessment
    • Generates medical follow-up queries and contact reporters if necessary
    • Organize the workflow for a given task or project
    • Ensure that given timelines are met according to project and regulatory timelines
    • Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs)
    • Perform CSR signal/trend detection
    • Perform aggregate line listing signal/trend detection
    • Contributes in evaluation of emerging safety issues
    • Contributes in evaluation benefits and risks of a medical compound
    • Evaluate laboratory values for potential SAEs
    • Review SAE and AE coding to ensure medical accuracy with the verbatim reported term
    • Participate in Quality Check activities
    • Provides therapeutic training relevant to specific study to the project team.
    • Ensure medical and scientific input in study protocols and reports
    • Prepare internal SOPs and project specific procedures
    • Write/participate in writing safety reports (RMPs, PSURs/PEBERs, ARs, SBRs, Issue workups, annual reports/DSURs)
    • Keep up to date about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology
    • Attends and/or presents at internal and external project team meetings.

Qualifications

  • 2 Years experience reviewing ICSR
  • Licensed physician
  • Good communications and presentation skills.
  • Experience using computerized systems (PC-Windows and MS Office).
  • Read, write, and speak fluent English; fluent in host country language.
  • Good project management skills.
  • Experience in mentoring more junior team members.
  • Clinical practice and/or clinical research or drug safety experience.
  • Broad knowledge of regulatory requirements.

 

Legal Statement:

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities

 

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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