Senior Specialist, Clinical Patient Safety and Pharmacovigilance Operations at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree in healthcare or life sciences (e.g., RN, BSN, PharmD preferred)
Minimum of 3 years Drug Safety/Pharmacovigilance experience in a global environment
Experience in clinical trial safety operations (preferred)
Working knowledge of FDA, EU, and ICH guidelines for safety reporting
Knowledge of Argus (or similar safety applications), electronic data capture systems, MedDRA, and WHO Drug coding dictionaries
Ability to work in a dynamic, fast-paced environment, collaborate with cross-functional teams, and manage multiple projects
Excellent verbal and written communication skills
Able to travel up to 10% of time
Flexibility to be in office more than 3 days per week (hybrid role, at least 3 days on-site in Redwood City, CA)
Currently authorized to work in the United States on a full-time basis

Responsibilities

Support oversight of safety vendors for high-quality collection, processing, reporting, and reconciliation of adverse event reports in compliance with global regulatory requirements, including 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)
Manage PSPV mailboxes, including supporting intake reconciliation
Develop and maintain departmental SOPs, work instructions, and training materials
Deliver 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

Skills

Key technologies and capabilities for this role

PharmacovigilancePatient SafetyICSRAdverse Event ReportingRegulatory ComplianceSAE ReconciliationSafety Management PlansVendor OversightClinical TrialsTrial Master File

Questions & Answers

Common questions about this position

Is this a remote role or does it require office presence?

This is a hybrid role typically requiring on-site presence at least 3 days per week in Redwood City, CA, with flexibility to be in office more than 3 days a week to meet business needs like audits or regulatory inspections.

What are the key skills required for this position?

Key skills include knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries, along with excellent communication skills, ability to collaborate with cross-functional teams, and manage multiple projects.

What is the salary or compensation for this role?

This information is not specified in the job description.

What education and experience are preferred for this role?

A Bachelor's degree in healthcare or life sciences is preferred.

What is the work environment like at Corcept Therapeutics?

The role involves working in a dynamic, fast-paced environment, with the ability to collaborate with cross-functional teams, vendors, and investigator sites, and up to 10% travel.

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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