Manage end-to-end PV package preparation, quality control, and compliance tracking.
Oversee PV mailbox operations, query triage, and stakeholder communication.
Ensure inspection readiness through documentation governance and audit support.
Indegene is a technology-led healthcare solutions provider that enables healthcare organizations to be future-ready. We offer accelerated growth opportunities and a culture of entrepreneurship, innovation, collaboration, and empathy.
Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
Oversee collection, evaluation, and reporting of safety data from clinical trials, shaping the safety governance framework.
Manage PV vendor contracts, quality/compliance for ICSR case processing, and mentor PV operations associates.
MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.
Lead safety review and risk management activities for assigned products.
Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
Support global regulatory submissions and health authority interactions.
Alphanumeric is a company that provides scientific and clinical safety expertise, supporting global organizations in pharmacovigilance and risk management. The company culture emphasizes independent work and collaboration across global teams.
Provide medical oversight for clinical trials, safeguarding participant safety and ensuring protocol compliance.
Review adverse events and safety data, contributing to regulatory reporting and clinical documentation.
Collaborate with investigators and clinical teams to support study design, execution, and risk management.
This position is listed on behalf of a partner company that manages all applications and next steps. The role supports global clinical research in a remote working environment with cross-functional collaboration.
Serve as primary medical and scientific expert for clinical trial protocols and Expanded Access Programs.
Monitor trials to ensure participant safety, data accuracy, and protocol compliance.
Lead protocol development, investigator training, and cross-functional collaboration.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trials, expanded access programs, and market access solutions. With 15+ years of experience across 150+ countries, they offer operational scale and a personalised culture.