Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations Job at Corcept Therapeutics, Redwood City, CA

ZElWN3Z4VDd1Q0hBUE5qZGxRZGpOb2pUT1E9PQ==
  • Corcept Therapeutics
  • Redwood City, CA

Job Description

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit .

The role supports drug safety and pharmacovigilance activities in post-marketing setting focusing on supporting case management activities, particularly focused on the oversight of quality and compliance of vendor/service provider activities.

Responsibilities:

  • Support the oversight of drug safety/pharmacovigilance service providers to ensure the collection, processing, reporting and reconciliation of adverse events reports in compliance with global regulatory requirements
  • Perform in line and/or end of line quality review of adverse event reports
  • Assists in the creation/revision of department standard operating procedures and work instructions
  • Development and delivery of training for safety related topics
  • Support process improvement initiatives and safety systems activities
  • Support and participate in audits and inspections, including preparation activities
  • Assist with safety operations and/or safety science activities and projects, as necessary

Required 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) and MedDRA and WHO Drug coding dictionaries
  • Excellent communication and collaboration skills
  • Ability to manage multiple projects in a fast-paced environment

Education and Experience:

  • Bachelor's degree in healthcare or life sciences- degree such as RN or BSN, PharmD is preferred
  • Minimum of 3 years Patient Safety & Pharmacovigilance experience in a global environment
  • Experience in post marketing safety operations preferred
  • Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing

The pay range that the Company reasonably expects to pay for this position is $103,600 - $137,100; 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.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Please visit our website at:

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Job Tags

Full time

Similar Jobs

LC GROUP

Remote Customer Experience Representative Job at LC GROUP

 ...service in a fast-paced environment. Requirements Strong communication skills Ability to work independently from home Basic computer and typing skills Reliable internet connection Customer service experience preferred but not required... 

Optimal Dispatch Service LLC

Owner-Operator CDL-A Drivers (Dedicated Freight Support) Job at Optimal Dispatch Service LLC

 ...Industry/Category: Logistics Level: Experienced Position Overview: Dedicated freight lanes are available for CDL-A owner-operators. This role is structured to support steady operations through coordinated workflows. Responsibilities: Transport freight... 

Humana

BILINGUAL FL Medicaid Call Center Representative Job at Humana

 ...community and help us put health first Do you have a desire to work from home? Do you love assisting others when they are in need? Are you...  ...multiple software systems including email, chats, efficient typing skills, and toggling across multiple databases while engaging... 

Byrider

Collections Manager Job at Byrider

Pay:$60,000.00 - $75,000.00 per year Job description: Address: 8224 Washington Ave, Mt Pleasant, WI 53406 Branch Finance Manager Byrider is growing! Branch Finance Manager career opportunity at a top location!$60K$75K Base + Bonus | $100K Potential ...

BioMarin Pharmaceutical Inc.

Pharmacovigilance Associate II Job at BioMarin Pharmaceutical Inc.

 ...science. With this distinctive approach to drug discovery, we've produced a diverse...  ...to actively and effectively monitor the safety of Pharmacovigilance products throughout...  ...global PV compliance. Summary The Associate is responsible for case initiation, data...