Pharmacovigilance Specialist

5 days ago

Ridgefield, Connecticut, United States McInnis Inc. Full time
Job Summary

We are seeking a highly skilled Pharmacovigilance and Safety Specialist to join our team at McInnis Inc. The ideal candidate will have a strong background in pharmacovigilance, risk management, and analysis of safety data.

Key Responsibilities
  • Assess individual clinical trials 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.
  • Performing 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
Preferred Qualifications
  • Oncology experience is highly preferred.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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