Senior Manager, Pharmacovigilance

ORIC Pharmaceuticals Inc.

Senior Manager of Pharmacovigilance at ORIC Pharmaceuticals managing global pharmacovigilance activities for oncology products. Ensuring compliance with safety regulations and collaborating with cross-functional teams.

Posted 7/15/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $150,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing pharmacovigilance activities for clinical trials and post-approval oncology products, with a strong understanding of global regulations and safety reporting processes.

Highest-signal resume keywords

Pharmacovigilance ManagementClinical Trial Safety Data ReviewRegulatory SubmissionsSafety Management Plans DevelopmentOncology Products Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceMedical ReviewSignal DetectionRisk EvaluationData CleaningSafety ReportingSafety Data Exchange AgreementsSafety Management PlansClinical Study ProtocolsInformed Consent Forms

Soft Skills

CollaborationCommunicationTraining

Tools & Technologies

ArgusARISgClinical Trial Databases

Industry Keywords

OncologyGlobal Pharmacovigilance RegulationsFDAEMAHealth CanadaJapan PMDASouth Korea MFDS

About the role

Key responsibilities & impact

Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
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
Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained

Requirements

What you’ll need

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

Benefits

Comp & perks

Health insurance
Retirement plans
Flexible work arrangements
Paid time off
Professional development opportunities