Corcept Therapeutics · 1 month ago
Senior Specialist, Clinical Patient Safety and Pharmacovigilance Operations
Redwood City, California, United States
Full-time
Hybrid
Mid, Senior Level
$123K/yr - $146K/yr
3+ years expCorcept Therapeutics is leading the way in the research and development of cortisol modulators to treat serious diseases. The Senior Specialist, Clinical Patient Safety and Pharmacovigilance Operations will support Patient Safety and Pharmacovigilance Safety Operations activities in clinical trial settings, ensuring compliance with global regulatory reporting requirements and managing safety operations activities.
BiotechnologyMedicalPharmaceutical
Responsibilities
Support the oversight of safety vendors to ensure high quality delivery in the collection, processing, reporting, and reconciliation of adverse event reports in compliance with global regulatory reporting requirements, including but not limited to:
Performing quality review of individual case safety reports (ICSRs)
Monitoring case volume and workflow timelines
Support review of expedited and aggregate report submissions, including quality review and archival of records
Perform safety operations study start-up activities, e.g., developing safety management plans, study forms, completion guidelines, safety related training
Perform ongoing and end of study safety operations clinical trial activities, e.g., SAE reconciliation, Trial Master File maintenance, assigning study-specific training to PSPV personnel and vendors
Managing PSPV mailboxes, including supporting intake reconciliation
Develop and maintain departmental SOPs, work instructions, and training materials
Delivery training to internal teams, Investigator sites and/or vendors
Support and participate in audits and inspections, including preparation activities
Assist with additional PSPV projects as requested
Qualification
Required
Support the oversight of safety vendors to ensure high quality delivery in the collection, processing, reporting, and reconciliation of adverse event reports in compliance with global regulatory reporting requirements, including but not limited to: Performing quality review of individual case safety reports (ICSRs)
Monitoring case volume and workflow timelines
Support review of expedited and aggregate report submissions, including quality review and archival of records
Perform safety operations study start-up activities, e.g., developing safety management plans, study forms, completion guidelines, safety related training
Perform ongoing and end of study safety operations clinical trial activities, e.g., SAE reconciliation, Trial Master File maintenance, assigning study-specific training to PSPV personnel and vendors
Managing PSPV mailboxes, including supporting intake reconciliation
Develop and maintain departmental SOPs, work instructions, and training materials
Delivery training to internal teams, Investigator sites and/or vendors
Support and participate in audits and inspections, including preparation activities
Assist with additional PSPV projects as requested
Preferred
Ability to work in a dynamic environment to meet patient and corporate needs
Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
Excellent communication skills (verbal and written)
Ability to collaborate with cross-functional teams and manage multiple projects in a fast-paced environment
Able to travel for up to 10% of time
Flexibility to be in office more than 3 days week to meet any business needs (e.g., audits, regulatory inspections)
Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD is preferred
Minimum of 3 years Drug Safety/PV experience in a global environment
Experience in clinical trial safety operations is preferred
Working knowledge of FDA, EU, and ICH guidelines for safety reporting
Able to travel for up to 10% of time
Must be willing and have flexibility to come to office more than 3 days week to meet business needs (e.g., regulatory inspections)
Company
Corcept Therapeutics
Corcept Therapeutics discovers and develops drugs that regulate the effects of cortisol.
501-1000 employees
H1B Sponsorship
Corcept Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (4)
2023 (4)
2022 (3)
Funding
Current Stage
Public CompanyTotal Funding
$119.09MKey Investors
Paperboy Ventures
2012-07-02IPO
2012-04-10Post Ipo Equity· $0.53M
2011-01-21Post Ipo Equity· $39M
Leadership Team
Roberto Vieira
President, Oncology
Yuan Xu
Associate Director, Statistical Programming
Recent News
Company data provided by crunchbase