Pharmacovigilance Specialist

1 day ago

Ridgefield, Connecticut, United States McInnis Inc. Full time
Pharmacovigilance and Safety Position

McInnis Inc. is seeking a highly skilled Pharmacovigilance and Safety professional to join our team. As a key member of our Pharmacovigilance and Safety department, you will be responsible for assessing individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.

Key Responsibilities:

  • Assess individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.
  • Assess seriousness, expectedness, and causality.
  • Query for additional medical information needed to understand, analyze, and assess the case reports.
  • Write individual case assessments.
  • Interpret aggregate safety data as needed.
  • 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.

Requirements:

  • 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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