The Senior Manager of Pharmacovigilance will be responsible for the execution of global pharmacovigilance activities supporting late-stage clinical development and preparation for first commercial launch of small-molecule oncology products in lung and prostate cancer. This role will ensure compliance with global safety regulations and will work closely with cross-functional partners to ensure individual case safety report (ICSR) processing, Health Authority submissions, and post-marketing safety readiness. This is a hands-on role well suited for a biotech environment requiring both operational excellence and cross-functional collaboration. **Job Description** **Global Drug Safety & Pharmacovigilance Operations** - Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products - In partnership with Clinical Research Organizations (CROs), oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines - Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partners - Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs) - Develop, maintain and execute Safety Management Plans for clinical studies **Clinical Development & Regulatory Affairs Support** - Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable) - Review clinical trial safety data and assist with data cleaning for ongoing studies - Participate in periodic safety reviews, signal detection and risk evaluation activities - Maintain Reference Safety Information for ORIC products and co-administered IMPs - Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable) - Assist with preparation for regulatory inspections and audits **Cross-Functional Collaboration** - Participate in internal Safety Management Teams and governance meetings - Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams - Support safety training for internal stakeholders and investigators **Vendor & Compliance Oversight** - Support oversight of pharmacovigilance vendors and service providers - Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained - Assist in development and maintenance of SOPs and training materials **Qualifications** **Required Qualifications** - Bachelor's degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology - 12 years' pharmacovigilance experience with Bachelor's degree -or- 8 years' experience and Master's degree -or- 5 years' experience and PhD-including clinical trial and/or post-marketing experience - Experience with small-molecule oncology products - Working knowledge of global pharmacovigilance regulations, including FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS) - Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases **Preferred Qualifications** - Oncology experience in lung and/or prostate cancer - Experience in biotech/ small pharmaceutical company or CRO environments - Experience supporting NDA/MAA submissions and commercial launch - Familiarity with REMS, RMPs, and post-marketing commitments **Skills and Attributes** - Strong strategic thinking combined with a hands-on, execution-focused mindset - Proven ability to collaborate and lead in a cross-functional, matrixed organization - Excellent written and verbal communication skills, with the ability to convey complex data clearly - Highly organized, adaptable, and comfortable working in a fast-paced, evolving environment - Mission-driven, patient-focused, and committed to scientific integrity **Additional Information** The anticipated salary range for candidates who will work on-site at our San Diego location is between $150,000-$180,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. This position is not eligible for H-1B visa sponsorship.