Pharmacovigilance Consultant (Part-Time or Contract)
Location: Madison, WI (Hybrid Preferred)
Focus: Psychedelic CNS Clinical Trials – Psilocybin
Start: As Soon As Available | Duration: 6–12 months (extendable)
Usona Institute is a medical research organization committed to advancing the science of consciousness and alleviating human suffering through psychedelic medicine. As we advance our late-phase clinical program for psilocybin, we are seeking a detail-oriented Pharmacovigilance Consultant to join our team on a flexible basis.
Your Role:
Support the pharmacovigilance strategy and operations for ongoing IND clinical trials, including:
1. Reviewing and assessing adverse event (AE) and serious adverse event (SAE) case data.
2. Authoring and reviewing MedWatch reports (Form 3500A) and narrative summaries.
3. Ensuring timely and compliant FDA safety reporting (21 CFR 312.32).
4. Supporting DSUR preparation and SAE reconciliation with clinical sites and CRO partners.
5. Advising on safety database outputs, signal detection, and regulatory inspections.
Qualifications:
1. PharmD, MD, or advanced scientific degree preferred.
2. 5+ years experience in clinical pharmacovigilance (IND/NDA environment).
3. Strong understanding of MedDRA coding, ICH E2A/B/G, and FDA expectations.
4. Familiarity with CNS/psychiatry trials or psychedelic medicine a plus.
5. Excellent communication and collaborative skills.
Why Join Usona?
-Join a mission-driven, non-profit research institute at the forefront of psychedelic medicine.
-Work with a small, expert team engaged in transformative clinical research.
-Flexible hours and potential for remote or hybrid work.
-Located in beautiful Madison, Wisconsin.
Interested?
Email us directly at Molly.Lenzendorf@Promega.com with your CV. Referrals welcome!
At Usona Institute, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.
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