Senior Global Pharmacovigilance Scientist

🔥 43 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $148k - $160k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Belite Bio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $402M Post-IPO Equity on 2025-12

Biotechnology • Pharmaceuticals

Belite Bio is a clinical-stage biopharmaceutical company developing novel therapeutics based on its RBP4 (Retinol Binding Protein 4) intellectual property portfolio. Its lead candidate, tinlarebant (LBS-008), is an oral therapy designed to reduce toxic accumulations in the eye and is being developed for retinal degenerative diseases including autosomal recessive Stargardt disease (STGD1) and Geographic Atrophy (advanced dry age-related macular degeneration). Belite Bio is conducting multiple clinical trials (Phase 1b/2, Phase 2/3, and Phase 3 programs such as DRAGON, DRAGON II, and PHOENIX) and tinlarebant has received several regulatory designations (Orphan Drug in US/EU/Japan, Rare Pediatric Disease, Breakthrough Therapy, Fast Track, and Sakigake). The company’s pipeline also includes programs addressing metabolic and liver diseases (e. g. , non-alcoholic fatty liver disease and type 2 diabetes).

📋 Description

• Collect and collate reported (S)AEs associated with Belite Bio products in development and post-authorization • Check reported information for completeness and consistency • Perform case assessments, including determining seriousness and reportability • Enter relevant data into the Pharmacovigilance database and edit narratives • Prepare follow-up queries and communicate with reporters to obtain additional information • Submit expedited individual case safety reports to FDA, EMA, Ethics Committees, partners and other applicable parties within required timelines • Develop database queries and data visualizations supporting aggregate reports, signal detection and reconciliation • Answer and support responses to competent-authority questions • Provide pharmacovigilance training to company and non-company personnel • Reconcile clinical-trial safety information with data management • Alert company personnel to possible adverse changes in product risk-benefit profiles • Coordinate PV Signal Detection Meetings under Medical-Safety Physician oversight • Monitor global pharmacovigilance legislation and update procedures, practices and database configuration • Design and implement procedures for smooth operation of the Pharmacovigilance Department • Support routine and for-cause GvP audits of partners/distributors • Oversee database setup for new studies and prepare study-specific SAE processing documents • Assist Business Development with safety-related proposal and contract matters • Hire, train and mentor junior staff • Report directly to the Head of Medical Safety, Global Pharmacovigilance

🎯 Requirements

• BS Degree in relatable subjects in biologic or natural science, or health care discipline (life sciences, pharmacy or nursing) • Significant and proven Pharmacovigilance experience • Minimum 3+ years of industry experience in case processing (ICSR), aggregate safety reports and signal detection • Extensive knowledge of common safety database (ARGUS) • Experience interacting with cross-functional teams such as Clinical Development and Regulatory • In depth understanding of good pharmacovigilance practices and current drug safety regulations • Good knowledge of GCP/ICH guidelines • Sufficient level of management and training expertise • Proven periodic reports writing experience • Extensive knowledge of pharmacovigilance, especially case processes, drug safety evaluation and signal detection • Masters or PharmD degree preferred

🏖️ Benefits

• Annual incentive bonuses • Equity participation • Health insurance • Dental insurance • Vision insurance • 401(k) • Paid time off • Reasonable accommodations for individuals with disabilities

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