Pharmacovigilance and Safety

1 week ago

Ridgefield, United States McInnis Inc. Full time

Pharmacovigilance and Safety

Provide services relating to adverse event reporting with a focus on Final Review step of case processing and any other responsibilities typically associated, but not limited to, the outlines and responsibilities detailed below.


20-40 hours per week

Medical License Required


Responsibilities of Contractor

  • Provide personnel/resources qualified to meet deliverable expectations as more completely described in the Responsibilities and Deliverables set forth below.
  • Along with Project Manager, review all timecards and any expense reimbursements for accuracy and adherence with policies.


Patient Safety & Pharmacovigilance Contract Physician Deliverables and Responsibilities:

  • Responsible for assessing individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.
  • Assessing seriousness, expectedness, and causality.
  • Querying for additional medical information needed to understand, analyze, and assess the case reports.
  • Writing individual case assessments.
  • Interpreting aggregate safety data as needed.
  • On an as needed basis, perform active phone follow-up on selected medically important cases on behalf of US Patient Safety & Pharmacovigilance (PSPV), in order to optimize safety data collection and analysis.
  • Scalable position requiring 20-40 hours per week.


This position is necessary for GPV to meet its corporate responsibilities to ensure all pharmacovigilance/risk management activities are performed in accordance with standard operating procedures and within regulatory timelines.


Required Experience:

  • 5+ years industry experience in pharmacovigilance/risk management and analysis of safety data.
  • Clinical Medicine experience with more than 1+ year of patient care required.
  • Excellent written & verbal communication skills.
  • Experience performing medical review and assessment of individual case safety reports and expedited reporting required.
  • General knowledge of medical computer programs.
  • Ability to learn computer database programs


Education:

  • Must have MD/ DO
  • Must have a Medical license (US or equivalent)
  • Must have at least one year of post license clinical experience.


Oncology experience is highly preferred.

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