Lead safety evaluations and benefit-risk assessments for assigned products.
Provide medical leadership for pharmacovigilance activities across development and marketed products.
Support regulatory submissions and health authority interactions, including preparing responses to RFIs.
Alphanumeric is a staffing and recruiting company that places professionals in contract roles with top organizations. This role is a 1-year contract with a major pharmaceutical company, supporting its global Safety Evaluation & Risk Management function.
Lead product safety surveillance strategies and risk management for investigational products.
Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations.
Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. It is a growing biotechnology company with a startup culture focused on making a difference.
Collects, reviews, and analyzes adverse event reports from clinical trials to identify potential safety signals.
Supports the preparation and review of pharmacovigilance documents such as DSURs, dRMPs, and relevant clinical trial sections.
Collaborates with cross-functional teams including clinical operations, regulatory affairs, and medical affairs.
Oruka Therapeutics is developing novel biologics designed to set a new standard for treating chronic skin diseases like plaque psoriasis. They are an early-stage public company (Nasdaq: ORKA) building a core team, seeking top talent to contribute to an engaged, inclusive, and positive culture.
Manage regulatory submissions and site activation for clinical trials in Spain, ensuring compliance and timelines.
Negotiate site contracts and budgets, and coordinate with Competent Authorities and Ethics Committees.
Maintain project trackers, oversee essential documents, and support translation activities for patient materials.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel trial designs, biomarkers, and data analytics. They focus strongly on rare diseases and oncology, and their culture emphasizes innovation, collaboration, and regulatory excellence.
Provide medical direction and oversight for clinical trials, including safety monitoring and medical data review.
Partner with GCO to build client relationships and support proposals, feasibility, and business development.
Serve as drug development SME, contributing to protocols, training, and medical strategy across studies.
Fortrea is a global contract research organization providing clinical development and trial management services to pharma/biotech. It fosters a collaborative, family-like culture focused on advancing life-saving therapies.
Establish and maintain a system to collect all suspected adverse reaction reports for company products.
Ensure requests from competent authorities for benefit-risk information are answered fully and promptly.
Oversee safety profiles, emerging safety concerns, and post-authorisation safety study commitments.
PrimeVigilance is a mid-size pharmacovigilance service provider and part of Ergomed PLC, supporting pharma and biotech partners with drug safety, regulatory affairs, and quality assurance. With staff across Europe, North America and Asia, it values well-being.