Responsibilities: Safety Strategy Oversight Lead pharmacovigilance strategy across clinical programs, ensuring alignment with overall clinical development plans. Serve as the safety lead on study teams, providing medical and scientific input on safety data interpretation and risk management. Contribute to the development and maintenance of safety-related documents, including DSURs, IBs, protocols, and safety sections of regulatory submissions (e.g., INDs/BLAs). Case Management Signal Detection Oversee case processing activities, including SAE review, medical assessment, and timely reporting in compliance with global regulations. Lead signal detection, evaluation, and risk assessment activities, including aggregate data review and benefit-risk evaluation. Ensure appropriate escalation and communication of safety signals to internal stakeholders and governance committees. Regulatory Compliance Inspection Readiness Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines. Support health authority interactions related to safety and pharmacovigilance. Contribute to inspection readiness activities and support audits and inspections as needed. Cross-Functional Collaboration Partner closely with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs to ensure integrated safety oversight across programs. Provide safety input into clinical trial design, study conduct, and data review processes. Collaborate with external vendors (e.g., CROs, safety databases) to ensure high-quality PV operations. Operational Leadership Establish and refine pharmacovigilance processes, systems, and infrastructure to support a growing clinical pipeline. Oversee PV vendors and ensure performance, quality, and compliance. Contribute to building scalable PV capabilities in preparation for late-stage development and potential commercialization. Qualifications: