Sr. Global Pharmacovigilance Scientist

Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases with significant unmet medical needs. Built on our proprietary Retinol Binding Protein 4 (RBP4) IP portfolio, our clinical pipeline includes Tinlarebant (LBS-008), an oral therapy currently in late-stage clinical trials (including the Phase 3 DRAGON and PHOENIX studies) for Stargardt disease (STGD1) and Geographic Atrophy (GA) in dry AMD.

At Belite Bio, we are dedicated to developing innovative solutions to treat untreatable conditions and prevent vision loss in patients worldwide. As an emerging, agile organization, we offer a fast-paced environment where dynamic self-starters thrive.

Operating at the forefront of drug development means our team members wear multiple hats, roll up their sleeves, and bring deep personal dedication to every project. If you are energized by a high-impact, hands-on culture where your effort directly shapes our growth and mission, you will find a rewarding home here.

About This Role

As a Sr. Global Pharmacovigilance Scientist, you will be responsible for a wide variety of matters in support of Belite Bio’s growth, including (S)AE reporting, case processing, perform data retrieval for signal detection and respond to regulatory agency safety enquiries, authoring aggregate reports like PSURs and DSURs. You'll delve into medical and scientific literature to extract vital safety information while supporting Clinical Trial PV medical activities. Collaborating with safety physicians, you will also hire, train, and mentor junior staff dedicated to product-specific tasks. Successful execution will involve in depth knowledge of current drug safety regulations and a sufficient level of management expertise. Your role as a Subject Matter Expert ensures compliance with global safety regulations and guidelines, fostering data analysis and product information sharing across cross-functional teams. This position is vital for maintaining the integrity and continuity of clinical trials and marketed products, ensuring they meet regulatory standards globally. This role reports directly to the Head of Medical Safety, Global Pharmacovigilance.

Key Responsibilities

• Collecting and collating reported (S)AEs associated with the use of Belite Bio’s product(s) both in development and post-authorization.
• Checking reported information on completeness and consistency of data.
• Performing case assessments including determining seriousness, reportability etc.
• Entering all relevant data in the Pharmacovigilance database including editing narratives.
• Preparing follow-up queries and communicating with the reporters to obtain follow-up information for the (S)AEs received. Responsible for expedited submission of individual case safety reports to competent authorities, i.e., FDA, EMA, Ethics Committees, partners and other parties as applicable within timelines specified per applicable legal requirement (e.g., 7/15 day reporting timeline).
• Developing data output: database queries and data visualization in support of internal stakeholder requests (aggregate reports, signaling outputs, reconciliation, etc).
• Answering and/or supporting/contributing to the answering of questions from competent authorities.
• Providing company or non-company personnel with PV training (e.g., non-PV staff within Belite Bio., CRAs, investigators, sales representatives, customer service, if needed).
• Performing reconciliation of safety information arising from clinical trials with data management.
• Alerting company personnel of any possible adverse changes to the risk-benefit profile of company products and providing relevant information as required to make an assessment.
• Under oversight of Medical-Safety Physician, co-ordinates the PV Signal Detection Meetings.
• Maintaining a current awareness of legislation and practices relating to PV and ensuring the company complies with changing global requirements through updating procedures, practices and database configuration as appropriate.
• Designing and implementing procedures to ensure the smooth running of the Pharmacovigilance Department.
• Ensuring compliance of partner/distributors with local pharmacovigilance agreements by supporting routine and for cause GvP audits.
• Overseeing the database set-up of all new studies including the preparation of study specific SAE processing documents (e.g., Safety Reporting Plan).
• Assisting Business Development in all safety related issues required for the preparation of proposals/contracts for partners/distributors.
• Performing other related duties as assigned or requested by the PV Senior Manager and the Head of Medical Safety, GPV.

Minimum Qualifications

• BS Degree in relatable subjects in biologic or natural science, or health care discipline (life sciences, pharmacy or nursing). Masters or PharmD degree preferred.
• Significant and proven Pharmacovigilance experience, including minimum 3+years of industry experience in case processing (ICSR), aggregate safety reports and signal detection.

Preferred Qualifications

• Extensive knowledge of common safety database (ARGUS) and experience in 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.

Equal Employment Opportunity & Accommodations

Belite Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Belite Bio is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the application or interviewing process due to a medical condition or disability, please contact human resources to let us know the nature of your request.

Salary Disclosure

Pay Range: $148,000 to $160,000 per year.  Salary offered will depend on candidate location, market rate adjustments, skills, and relevant experience.

Belite Bio provides a competitive total compensation package that includes base salary, annual incentive bonuses, equity participation, and a full benefit package (health, dental, vision, 401(k), and paid time off.