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Safety and Risk Management Professional

2 months ago

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

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

Key Responsibilities
  • Medical Review and Assessment: Assess individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.
  • Case Assessment and Reporting: Assessing seriousness, expectedness, and causality, querying for additional medical information needed to understand, analyze, and assess the case reports, writing individual case assessments, and interpreting aggregate safety data as needed.
  • Active Follow-up: 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.
  • Regulatory Compliance: Ensure all pharmacovigilance/risk management activities are performed in accordance with standard operating procedures and within regulatory timelines.
Requirements
  • Industry Experience: 5+ years of experience in pharmacovigilance/risk management and analysis of safety data.
  • Clinical Medicine Experience: Clinical Medicine experience with more than 1+ year of patient care required.
  • Communication Skills: Excellent written & verbal communication skills.
  • Medical Education: Must have MD/ DO, Must have a Medical license (US or equivalent), and Must have at least one year of post-license clinical experience.
Preferred Qualifications
  • Oncology Experience: Oncology experience is highly preferred.