Senior Manager, Pharmacovigilance

Company Description:ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.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 OperationsManage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology productsIn partnership with Clinical Research Organizations (CROs), oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelinesEnsure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partnersSupport preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs)Develop, maintain and execute Safety Management Plans for clinical studiesClinical Development & Regulatory Affairs SupportContribute 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 studiesParticipate in periodic safety reviews, signal detection and risk evaluation activitiesMaintain Reference Safety Information for ORIC products and co-administered IMPsSupport 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 auditsCross-Functional CollaborationParticipate in internal Safety Management Teams and governance meetingsPartner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teamsSupport safety training for internal stakeholders and investigatorsVendor & Compliance OversightSupport oversight of pharmacovigilance vendors and service providersEnsure Safety Data Exchange Agreements (SDEAs) are implemented and maintainedAssist in development and maintenance of SOPs and training materialsQualifications:Required QualificationsBachelor’s degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology12 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 experienceExperience with small-molecule oncology productsWorking 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 databasesPreferred QualificationsOncology experience in lung and/or prostate cancerExperience in biotech/ small pharmaceutical company or CRO environmentsExperience supporting NDA/MAA submissions and commercial launchFamiliarity with REMS, RMPs, and post-marketing commitmentsSkills and AttributesStrong strategic thinking combined with a hands-on, execution-focused mindsetProven ability to collaborate and lead in a cross-functional, matrixed organizationExcellent written and verbal communication skills, with the ability to convey complex data clearlyHighly organized, adaptable, and comfortable working in a fast-paced, evolving environmentMission-driven, patient-focused, and committed to scientific integrityAdditional 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.ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

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