About This RoleAs 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.
Salary DisclosurePay 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.
