Provide advanced toxicological analysis and consulting across human health risk assessment, chemical exposure, product safety, and regulatory compliance.
Critically review, interpret, and synthesise toxicological data, exposure assessments, and risk evaluations.
Serve as a senior subject matter expert supporting litigation, regulatory submissions, and complex technical evaluations.
J.S. Held is a global consulting firm that combines technical, scientific, financial, and strategic expertise to advise clients seeking to realize value and mitigate risk. The firm provides a comprehensive suite of services, products, and data that enable clients to navigate complex, contentious, and often catastrophic situations.
Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs.
Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products.
Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.
Centessa Pharmaceuticals is a pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity.
Conduct scientific review and evaluation of ICSRs and clinical trial SAEs.
Perform ongoing safety surveillance through analysis of adverse event data.
Support preparation, review, and scientific input into safety deliverables.
Centessa Pharmaceuticals is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. They are advancing a portfolio of high conviction programs with strong biological validation and their asset-centric model offers a unique R&D logic.
Engage key opinion leaders and healthcare professionals within the assigned territory.
Provide education on clinical data, adverse event management, and mechanism of action.
Collect and communicate clinical insights on the market environment and competition.
Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. They are developing advanced cell therapies across a diverse array of technology platforms and are headquartered in Somerset, New Jersey.
Provide medication management for individuals, including reconciliation and adherence counseling.
Collaborate with the interdisciplinary care team to develop individualized care plans.
Monitor and evaluate medication regimens to ensure clinical criteria are met.
Shields Health Solutions provides integrated support to patients and physicians. They are focused on improving the quality of patient care through personalized relationships with patients and prescribers. They provide equal employment opportunities to all employees and applicants for employment, prohibiting discrimination and harassment of any type.
Ensure oversight for assigned product pharmacovigilance activities.
Manage pharmacovigilance aggregate reports and stakeholder input to meet regulatory timelines.
Conduct safety surveillance and signal detection activities.
EyePoint is committed to preventing blindness by developing and commercializing innovative therapeutics. They operate with a science-based entrepreneurial culture. They value the trust of patients, employees, and the community.
Resolves assignments from Board, President, SDMD Head and Director of ICSR Line.
Ensures effective Line Management in assigned teams (up to 15 direct reports/line manager spread globally).
Supports Team leads with deviation management and Business Development and Proposals with any existing and new opportunities.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They offer services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. They value employee experience, well-being and mental health.
Support management of contract laboratories and milestones.
Oversee stability programs and data analysis.
Author analytical CMC sections of regulatory filings.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019 and continuously expanding, they are constantly searching for high-impact individuals to strengthen their patient-centric team.
Management and operational delivery of the clinical elements within a trial.
Successful execution of assigned trials and ensuring completion of trial deliverables.
Identify challenges to study timelines/deliverables and offer creative action plans.
Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.
Review payer PA policy documents for specialty medications and interpret coverage criteria.
Translate policy language into standardized, structured data fields.
Flag ambiguous, conflicting, or unclear policy language.
Quantile Health is a New York-based AI startup focused on expanding patient access to medicines and cutting commercial research costs for the life science industry. They are a fast-growing company using AI agents.