Pharmacovigilance Clinical Scientist
Company: Pharmaceutical Company
- Location: South San Francisco, United States
- Seniority: Senior
- Employment type: Contract
- Posted: 12 days ago
- Offer language: English
Job description
We are seeking an experienced Senior Pharmacovigilance (PV) Clinical Scientist to support the US Patient Safety PV Compliance team. This role focuses on clinical review of Individual Case Safety Reports (ICSRs), adverse event assessment, case processing quality, regulatory compliance, and continuous process improvement.
The ideal candidate will bring strong pharmacovigilance expertise, clinical judgment, medical writing skills, and experience working with internal teams and external vendors to maintain high-quality drug safety operations and regulatory compliance.
Key Responsibilities
- Review and evaluate adverse event (AE) reports and ICSRs for completeness, validity, seriousness, causality, and labeling requirements.
- Perform clinical quality reviews of safety cases processed internally and by external vendors.
- Ensure accurate and timely case processing in the global safety database in accordance with company SOPs and applicable regulatory requirements.
- Monitor case quality trends, identify processing errors, analyze error rates, and assess potential compliance risks.
- Prepare quarterly executive summaries and reports highlighting quality trends and opportunities for improvement.
- Develop, update, and maintain SOPs, training materials, follow-up templates, and process documentation.
- Support regulatory submissions and ensure compliance with applicable FDA, EMA, ICH, and global pharmacovigilance requirements.
- Lead training initiatives for internal teams and external vendors on case processing, quality standards, and safety procedures.
- Coordinate adverse event follow-up activities, data corrections, case reconciliation, and case transmission verification.
- Monitor vendor performance, identify quality gaps, and recommend corrective and preventive actions.
- Collaborate with cross-functional teams on drug safety data exchange, technical product complaints, and medical product complaints.
- Support audits, inspections, process improvement projects, and implementation of updated regulatory requirements.
Required Qualifications
- Healthcare professional degree, such as RN/BSN/MSN, NP, RPh, BPharm, PharmD, or MD.
- Minimum 5–7 years of pharmacovigilance experience in a biopharmaceutical environment, or equivalent clinical experience with a strong understanding of drug safety regulations.
- Strong understanding of ICSR processing, adverse event assessment, and pharmacovigilance compliance.
- Knowledge of FDA safety regulations, ICH guidelines, EMA regulations, and applicable global PV requirements.
- Medical or scientific writing experience.
- Computer proficiency and data entry experience.
- Project management experience.
- Strong analytical, communication, documentation, and problem-solving skills.
Preferred Qualifications
- Experience with clinical review and quality oversight of vendor-processed safety cases.
- Experience with global safety databases, case reconciliation, and regulatory submissions.
- Experience developing SOPs, training teams, and driving pharmacovigilance process improvements.
