Pharmacovigilance Specialist

2 days ago

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

Job Title: Pharmacovigilance and Safety

Job Summary:

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

Responsibilities:

  • Medical Review and Assessment: Assess individual clinical trials and spontaneous case reports for medical review and regulatory reporting determination.
  • Case Assessment: Assessing seriousness, expectedness, and causality of individual case reports.
  • Querying and Follow-up: Querying for additional medical information needed to understand, analyze, and assess the case reports, and performing active phone follow-up on selected medically important cases as needed.
  • Writing and Reporting: Writing individual case assessments and interpreting aggregate safety data as needed.
  • Regulatory Compliance: Ensuring all pharmacovigilance/risk management activities are performed in accordance with standard operating procedures and within regulatory timelines.

Requirements:

  • Industry Experience: 5+ years of industry 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 and verbal communication skills.
  • Computer Skills: General knowledge of medical computer programs and ability to learn computer database programs.

Preferred Qualifications:

  • Oncology Experience: Oncology experience is highly preferred.

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