Corcept Therapeutics
Specialist/Senior Specialist, Clinical Patient Safety and Pharmacovigilance Oper
Corcept Therapeutics, Redwood City, California, United States, 94061
Specialist/Senior Specialist, Clinical Patient Safety and Pharmacovigilance Operations
Redwood City, California, United States
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators; in 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Our team continues to unlock the possibilities of cortisol modulation as a way to treat serious diseases.
This is a hybrid role typically requiring on-site presence at least 3 days per week in Redwood City, CA. The role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in clinical trial settings.
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, and 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 Skills, Qualifications and Technical Proficiencies
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 a week to meet any business needs (e.g., audits, regulatory inspections)
Preferred Education and Experience
Bachelor's degree in healthcare or life sciences 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 a week to meet business needs (e.g., regulatory inspections)
The pay range that the Company reasonably expects to pay for this headquarters‑based position is $102,700–$145,000. The pay ultimately offered may vary based on legitimate considerations, including geographic location, job‑related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full‑time basis.
Corcept is an Equal Opportunity Employer.
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Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators; in 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Our team continues to unlock the possibilities of cortisol modulation as a way to treat serious diseases.
This is a hybrid role typically requiring on-site presence at least 3 days per week in Redwood City, CA. The role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in clinical trial settings.
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, and 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 Skills, Qualifications and Technical Proficiencies
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 a week to meet any business needs (e.g., audits, regulatory inspections)
Preferred Education and Experience
Bachelor's degree in healthcare or life sciences 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 a week to meet business needs (e.g., regulatory inspections)
The pay range that the Company reasonably expects to pay for this headquarters‑based position is $102,700–$145,000. The pay ultimately offered may vary based on legitimate considerations, including geographic location, job‑related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full‑time basis.
Corcept is an Equal Opportunity Employer.
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