PV Clinical Scientist – Pharmacovigilance / Drug Safety
Company: Tranzeal Incorporated
- Location: South San Francisco, United States
- Work mode: Hybrid
- Seniority: Mid level
- Employment type: Contract
- Posted: 12 days ago
- Offer language: English
Job description
Job Title: Senior PV Clinical Scientist – Pharmacovigilance / Drug Safety
Location: South San Francisco, CA - Hybrid
Duration: Long Term Contract Position
Job Summary:
We are seeking an experienced Senior PV Clinical Scientist to support pharmacovigilance compliance, drug safety monitoring, and clinical review of adverse event cases. The candidate will be responsible for ICSR quality review, regulatory compliance, vendor oversight, and process improvement activities.
Key Responsibilities:
- Review and assess adverse event (AE) reports and Individual Case Safety Reports (ICSRs).
- Perform clinical case reviews, causality assessments, seriousness assessments, and labeling evaluations.
- Ensure compliance with FDA regulations, ICH guidelines, EMA requirements, and global PV standards.
- Monitor case-processing quality, identify errors, and prepare quality trend reports.
- Develop SOPs, training materials, and medical/scientific documentation.
- Support vendor oversight, audits, inspections, and process improvement initiatives.
Required Qualifications:
- Healthcare professional degree: PharmD, BPharm, RPh, MD, RN/BSN, or MSN.
- Strong knowledge of pharmacovigilance, drug safety, and ICSR processing.
- Knowledge of FDA, ICH, EMA, and global PV regulations.
- Medical/scientific writing, computer proficiency, and project management skills.
- 5–7 years of biopharmaceutical pharmacovigilance experience preferred.
