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About the Role
The Sr. PV Clinical Scientist supports US Patient Safety by providing expert clinical review, evaluation, and quality oversight of Individual Case Safety Reports (ICSRs) and adverse event (AE) information. This role ensures compliance with company SOPs, PV regulations, and global requirements. The position works autonomously as a subject matter expert, supports vendor oversight, drives quality and process improvements, and may lead projects and train teams.
Responsibilities
- Conduct clinical review and quality assessment of AE/ICSR cases processed internally or by vendors.
- Evaluate case validity, seriousness, causality, labeling, and follow-up requirements.
- Ensure accurate and timely case processing in the global safety database.
- Monitor case quality, error trends, vendor performance, and potential compliance risks.
- Support PV compliance with FDA, ICH, EMA, GVP, and applicable global regulations.
- Lead process improvements, SOP updates, training initiatives, and quality trend reporting.
- Support vendor oversight, audits, inspections, reconciliations, and case transmission verification.
- Oversee follow-up activities, correspondence, and data corrections.
- Support technical and medical product complaint reporting and escalation.
- Collaborate with cross-functional teams and serve as a subject matter expert for safety-related activities.
- Prepare presentations, executive summaries, and scientific/medical documentation.
Requirements
- Healthcare professional degree such as RN/BSN/MSN, PharmD, RPh/BPharm, NP, MD, or related qualification.
- 5–7+ years of pharmacovigilance experience in a biopharmaceutical environment or equivalent clinical experience with strong knowledge of safety regulations.
- Strong experience with ICSR case processing and clinical review.
- Knowledge of FDA, ICH, EMA, GVP, and global pharmacovigilance regulations.
- Experience with medical/scientific writing, data entry, and project management.
- Strong analytical, communication, organizational, and problem-solving skills.
- Ability to work independently, manage complex issues, and collaborate effectively with internal teams and external vendors.
Skills
- Pharmacovigilance
- ICSR case processing
- Clinical review
- FDA regulations
- ICH regulations
- EMA regulations
- GVP regulations
- Global pharmacovigilance regulations
- Medical/scientific writing
- Data entry
- Project management
- Analytical skills
- Communication skills
- Organizational skills
- Problem-solving skills
Location
- South San Francisco, CA
Work Type
- Hybrid
- Long Term Contract
Experience Level
- 5-7+ years
Education Level
- RN/BSN/MSN
- PharmD
- RPh/BPharm
- NP
- MD
- Related qualification
Salary/Compensations
- $65/hr
Benefits
- Medical
- Dental
- Vision
- Paid Sick leave
- 401K
About the Company
- World leader in biotechnology and gene therapy.