Senior Global Pharmacovigilance Scientist

This is a fully remote position, open to applicants in California.

📋 Description

• Gather and compile reported (S)AEs related to Belite Bio products both during development and after authorization.

• Verify the completeness and consistency of reported information.

• Conduct case assessments, including evaluating seriousness and reportability.

• Input relevant data into the Pharmacovigilance database and revise narratives.

• Prepare follow-up inquiries and communicate with reporters to gather additional details.

• Submit expedited individual case safety reports to the FDA, EMA, Ethics Committees, partners, and other relevant parties within required timelines.

• Create database queries and data visualizations to support aggregate reports, signal detection, and reconciliation.

• Respond to and assist with inquiries from competent authorities.

• Provide pharmacovigilance training to both company and non-company personnel.

• Reconcile clinical-trial safety information with data management.

• Notify company personnel of potential adverse changes in product risk-benefit profiles.

• Coordinate PV Signal Detection Meetings under the supervision of the Medical-Safety Physician.

• Monitor global pharmacovigilance legislation and update procedures, practices, and database configurations accordingly.

• Design and implement procedures to ensure the efficient operation of the Pharmacovigilance Department.

• Support routine and for-cause GvP audits of partners and distributors.

• Oversee the database setup for new studies and prepare study-specific SAE processing documents.

• Assist Business Development with safety-related proposals and contract matters.

• Recruit, train, and mentor junior staff members.

• Report directly to the Head of Medical Safety, Global Pharmacovigilance.

⛳️ Requirements

• Bachelor's Degree in related fields such as biological or natural sciences, or a healthcare discipline (life sciences, pharmacy, or nursing).

• Significant and demonstrable experience in Pharmacovigilance.

• At least 3 years of industry experience in case processing (ICSR), aggregate safety reports, and signal detection.

• Extensive knowledge of common safety databases, particularly ARGUS.

• Experience collaborating with cross-functional teams, including Clinical Development and Regulatory.

• Deep understanding of good pharmacovigilance practices and current drug safety regulations.

• Good familiarity with GCP/ICH guidelines.

• Adequate level of management and training expertise.

• Proven experience in writing periodic reports.

• Comprehensive knowledge of pharmacovigilance, especially regarding case processes, drug safety evaluation, and signal detection.

• Master’s or PharmD degree is preferred.

🏝️ Benefits

• Annual incentive bonuses.

• Equity participation.

• Health insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• Paid time off.

• Reasonable accommodations for individuals with disabilities.