Pharmacovigilance Specialist

Job Title: Pharmacovigilance and Safety Specialist

Company: McInnis Inc.

Job Type: Full-time/Part-time

Location: Remote

Job Category: Healthcare/Pharmaceuticals

We are seeking a highly skilled Pharmacovigilance and Safety Specialist to join our team at McInnis Inc. The successful candidate will be responsible for assessing individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.

• Medical Review and Assessment: Assess individual clinical trial and spontaneous case reports for medical review and regulatory reporting determination.
• Case Assessments: Write individual case assessments and interpret 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.
• Scalable Position: This position is scalable and requires 20-40 hours per week.

• 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.
• 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 and ability to learn computer database programs.

• Medical Degree: Must have MD/DO.
• Medical License: Must have a Medical license (US or equivalent).
• Post-Licensure Experience: Must have at least one year of post-license clinical experience.

• Oncology Experience: Oncology experience is highly preferred.