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](https://www.globenewswire.com/Tracker?data=eooMg_hERq6eFqGDRd-83hX-Mst0lcYc1svXH2ckLupnk6vtLoglOqJIgTs8MHwL0QPw6PkR6mgqYlLD18BF8zpyJwfylpWEj3N581NQgB8SrNpUUBfl5o7bjLxRUCwPQl1WKkB-WM-PUt0weune6_p99pUrdMXnKUev5RBNt5SlNL-MjnKFBmhXLCjRuTE3lzMIJmdSFjkyo7oEeeNBI_CpUw2XrXA4Z79hhEKc-Zof-JpmV7cL1VcBVbcZid2daMWiR1QiUjFjJBu5_xxaWQ==), and follow us on [X](https://www.globenewswire.com/Tracker?data=LkLeYYGZ1oQEt1na2bEHz1i_5V_ANCJV914tcF8xKb3uJEMI74JlihUQrtDMbODZMg6o4Ve4Cm8gSTseAwt9W7qqiwhvJPqwuF_fm3eVQPZEsjSa91YvZN_vzIEsUUAISFW-w3ZrVKPJVA-7ENI28JS6V7MVNBwYkoML_tPwfN355GPp9EOqyMvF4XrmA-V-xndBLTfTnEP0EIZXNpQk8g==) or [LinkedIn](https://www.globenewswire.com/Tracker?data=GbNlnIwHngnq11YKEizZhZ60FnTxvbb3nyDpv4jAYm8kWEtHRz1Px7GwUkt0J_op_ePBIf-chEsXxfFk-dOJV0C42HhN_Ut9Anph0woHJkFnQsMAfVif4MM84lNccWH8lqQfJdoYm5Ib0apfW1RXUvbnu2rLEMVmFZFRBT6YinCsWzbyJviQuar2jyK3Ym6JvYuLW4DE-OXIUYAIhYYo8ZNZ042Ra2D86u8qkOZhwgw8md7M3r6HW4klqCbXs_ZzFlMUOmPBS4uLBi3ba7Fy7g==). 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
