Senior Manager, Pharmacovigilance

ORIC Pharmaceuticals • San Diego, CA

1d • $150,000 - $180,000 • Onsite

About The Position

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.

Requirements

• 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)
• 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

Nice To Haves

• 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

Responsibilities

• 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
• 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
• 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
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level