Serve as primary contact for project-related matters, managing client expectations to ensure satisfaction with PrimeVigilance services.
Prepare project scope and objectives based on signed agreements, and plan activities including deadlines and interim milestones.
Report to clients and PrimeVigilance management, including monthly reports for invoicing basis.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. The company operates across Europe, North America, South America, Asia, and Australia, fostering a culture built on kindness, flexibility, growth, and belonging.
Manage complex regulatory activities related to active pharmaceutical ingredients, including DIFA/DMF processes and lifecycle management.
Provide strategic guidance and risk management support for API documentation and supplier qualification.
Collaborate with multidisciplinary teams and external partners to ensure regulatory compliance and operational excellence.
The partner company is a player in the pharmaceutical industry, focusing on regulatory affairs and lifecycle management of innovative products. The team size and culture are not specified, but the role emphasizes collaboration, continuous improvement, and remote work based in Brazil.
Lead one or more client policy initiatives with a team, including policy analysis, client communications, and project tracking.
Drive your development through an annual growth process in partnership with your supervisor and the learning and development team.
Participate in new business development through research, proposal content, and marketing materials.
BerryDunn is a professional services firm that has helped businesses, nonprofits, and government agencies since 1974. The firm is client-centered and people-first, with a focus on learning, development, and well-being, and has been recognized for its diverse and inclusive workplace culture.
Provide strategic leadership and functional representation for complex projects, ensuring effective coordination and execution of regulatory tasks.
Act as a franchise liaison between Ergomed Plc and clients, assisting in securing new business by participating in bid defenses and contributing to proposals and budgets.
Offer expert regulatory guidance, training, and mentoring to junior staff, while driving department initiatives and managing change implementation.
PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. With a presence across Europe, North America, South America, Asia, and Australia, the company fosters a culture built on kindness, flexibility, growth, and belonging.
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.