ORIC Pharmaceuticals Inc. logo
ORIC Pharmaceuticals Inc.

Overcoming Resistance In Cancer

Senior Manager, Pharmacovigilance

ManagerManagerFull TimeRemoteSeniorTeam 51-200Since 2014H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

3 days ago

Salary

$150K - $180K / year

Seniority

Senior

Bachelor Degree12 yrs expEnglish

Job Description

Senior Manager, Pharmacovigilance

ORIC Pharmaceuticals Inc.

• 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

Job 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) and clinical trial databases

Benefits

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

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