Clinical Trial and Pharmacovigilance Expert
2 weeks ago
Job Title: Pharmacovigilance and Safety Specialist
Company: McInnis Inc.
Job Type: Full-time/Part-time
Location: Remote
Job Category: Healthcare/Pharmaceuticals
Job SummaryWe are seeking a highly skilled Pharmacovigilance and Safety Specialist to join our team. The successful candidate will be responsible for assessing individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.
Responsibilities- Medical Review and Assessment: Assess individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.
- Case Assessment: Assessing seriousness, expectedness, and causality of case reports.
- Querying for Additional Information: Querying for additional medical information needed to understand, analyze, and assess the case reports.
- Writing Case Assessments: Writing individual case assessments.
- Interpreting Aggregate Safety Data: Interpreting aggregate safety data as needed.
- Active Phone Follow-up: 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.
- Industry Experience: 5+ years 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 & verbal communication skills.
- Medical Review Experience: Experience performing medical review and assessment of individual case safety reports and expedited reporting required.
- Computer Skills: General knowledge of medical computer 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: Oncology experience is highly preferred.
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