VP, Global Pharmacovigilance & Drug Safety – Oncology

ORIC Pharmaceuticals

San Diego (CA)

On-site

USD 310,000 - 385,000

Full time

14 days+

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Job summary

ORIC Pharmaceuticals is seeking a Vice President of Pharmacovigilance and Drug Safety to lead the global safety function across oncology programs. You will oversee safety surveillance, signal detection, and risk management while ensuring regulatory compliance and inspection readiness.

The role requires guiding PV operations, collaborating with Clinical Development, Regulatory Affairs, and Medical Affairs, and mentoring a high-performing PV team to support late-stage development.

Qualifications

  • 12+ years of progressive experience in pharmacovigilance, clinical safety, or drug development within biotechnology/pharma.

Responsibilities

  • Develop and execute ORIC’s global pharmacovigilance strategy in alignment with regulatory requirements and company objectives.
  • Provide leadership for benefit-risk evaluation, safety surveillance, signal detection, and risk management across ORIC’s investigational products.
  • Own medical safety aspects of clinical development, including safety input into protocols, IBs, CSRs, and regulatory submissions.
  • Lead safety content for DSURs, PSURs, RM plans, ICFs, RSI, and regulatory filings.
  • Serve as senior safety advisor to the CMO and represent PV in governance committees.
  • Establish scalable PV systems, quality frameworks, and vendor partnerships for a growing oncology portfolio.
  • Partner with Clinical Development, Biostatistics, Regulatory Affairs, and Medical Affairs on safety signal assessments.
  • Communicate emerging safety information to stakeholders and regulatory authorities within appropriate timeframes.
  • Build and mentor a high-performing PV team across medical and operations functions.
  • Ensure inspection readiness and regulatory compliance, including CAPAs as needed.
  • Manage PV vendors and CROs for outsourced operations.

Skills

Strategic leadership
Cross-functional collaboration
Executive communication
Autonomy in fast-paced environment

Job description

ORIC Pharmaceuticals is seeking a Vice President of Pharmacovigilance and Drug Safety to lead the global safety function across oncology programs. You will oversee safety surveillance, signal detection, and risk management while ensuring regulatory compliance and inspection readiness.

The role requires guiding PV operations, collaborating with Clinical Development, Regulatory Affairs, and Medical Affairs, and mentoring a high-performing PV team to support late-stage development.

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