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Senior Manager, Drug Safety Operations

Employer
Corcept Therapeutics
Location
Menlo Park, CA
Start date
Feb 20, 2024

View more

Discipline
Administration, Clinical, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

At Corcept Therapeutics, we believe the potential impact of cortisol modulation on the future of health has long gone overlooked. That is why for twenty-five years we have pushed the boundaries of what is possible, driven by fiercely independent science, open collaboration and the curiosity to follow the data wherever it leads.

Our company is committed to building a culture that values diverse perspectives and the unique contributions of every employee. Our vibrant community is made up of over 300 people—medical practitioners, scientists, and industry professionals—all with the shared goal of advancing the science of cortisol modulation to treat serious disease.

Our work has uncovered over 1000 proprietary selective cortisol modulators, including our marketed product, Korlym® (mifepristone), the first treatment available for those living with Cushing’s syndrome, a life-threatening condition caused by excess cortisol activity. Today, we have a unique opportunity to revolutionize the treatment of severe endocrine, oncology, metabolism and neurology disorders and aim to deliver better outcomes for the people affected by them.

We are looking for an experienced Senior Manager, Drug Safety Operations, who will provide technical and process-related support for clinical trials. The Senior Manager will be integral in the day-to-day functioning and overall development of the Drug Safety team. The successful candidate will report to the Associtate Director, Drug Safety Operations, and will function in a company matrix environment with several key groups including Biometrics, Clinical Development, Data Management, Regulatory Affairs, and Quality Assurance to ensure proactive safety surveillance, drug safety and risk management activities.

The incumbent will contribute to a full range of drug safety activities including vendor management, oversight of case processing/submissions, aggregate report submissions.  Maintains positive relationships with all Corcept personnel involved in Safety to ensure compliance and will participate in other Safety-related activities as needed.

Responsibilities:

  • Manage Drug Safety and Pharmacovigilance (PV) service provider(s) responsible for collection, processing and reporting of individual case safety reports (ICSRs) from clinical trials.
  • Develop and maintain Drug Safety and PV related documents including but not limited to SOPs, Work Instructions, Safety Management Plans (SMPs), and SAE/Pregnancy forms.
  • Supports the development and implementation process improvements, tools, and systems for Drug Safety & PV to enable excellence and consistency of activities in collaboration with other stakeholders.
  • Serve as Safety Operations Lead on Study Management Team(s).
  • Ensures all cases meeting regulatory reporting are submitted to regulatory authorities/CECs/ECs/Sites etc in accordance with internal guidelines, SMPs, SOPs and applicable regulations.
  • Oversees annual and/or periodic safety report regulatory submissions performed by vendor globally.
  • Reviews regulatory reporting requirements for ICSR/Annual/periodic safety report submissions.
  • Defining and applying a high standard of quality review of ICSRs processed by vendor.
  • Performs reconciliation of safety data in global safety and clinical trial databases to ensure high quality data capture in the databases.
  • Maintains assigned study TMFs in auditable state at all times. Works collaboratively with the vendor for outsourced TMF activities.
  • Liaise with safety physicians, medical monitors, or other cross functional teams as needed on safety data issues.
  • Acts as a Subject Matter Expert (SME) with regards to processing of ICSRs
  • Documents deviations and supports the development and implementation of CAPAs, as applicable
  • Assists in the management of pharmacovigilance audits and inspections.
  • Represents and presents Drug Safety at Investigator meetings.
  • Supports the review of vendor billing and invoices.
  • Identifies issues/concerns in a timely and appropriate manner.
  • Assists with the mentorship and training of junior team members.
  • Other assigned duties and/or projects as directed by management.

Preferred Skills, Qualifications and Technical Proficiencies:

  • Manage Drug Safety and Pharmacovigilance (PV) service provider(s) responsible for collection, processing and reporting of individual case safety reports (ICSRs) from clinical trials.
  • Develop and maintain Drug Safety and PV related documents including but not limited to SOPs, Work Instructions, Safety Management Plans (SMPs), and SAE/Pregnancy forms.
  • Supports the development and implementation process improvements, tools, and systems for Drug Safety & PV to enable excellence and consistency of activities in collaboration with other stakeholders.
  • Serve as Safety Operations Lead on Study Management Team(s).
  • Ensures all cases meeting regulatory reporting are submitted to regulatory authorities/CECs/ECs/Sites etc in accordance with internal guidelines, SMPs, SOPs and applicable regulations.
  • Oversees annual and/or periodic safety report regulatory submissions performed by vendor globally.
  • Reviews regulatory reporting requirements for ICSR/Annual/periodic safety report submissions.
  • Defining and applying a high standard of quality review of ICSRs processed by vendor.
  • Performs reconciliation of safety data in global safety and clinical trial databases to ensure high quality data capture in the databases.
  • Maintains assigned study TMFs in auditable state at all times. Works collaboratively with the vendor for outsourced TMF activities.
  • Liaise with safety physicians, medical monitors, or other cross functional teams as needed on safety data issues.
  • Acts as a Subject Matter Expert (SME) with regards to processing of ICSRs
  • Documents deviations and supports the development and implementation of CAPAs, as applicable
  • Assists in the management of pharmacovigilance audits and inspections.
  • Represents and presents Drug Safety at Investigator meetings.
  • Supports the review of vendor billing and invoices.
  • Identifies issues/concerns in a timely and appropriate manner.
  • Assists with the mentorship and training of junior team members.
  • Other assigned duties and/or projects as directed by management.

Preferred Education and Experience:

  • Bachelor's degree in healthcare or life sciences is required (RN or BSN, PharmD is preferred).
  • Minimum of 7 years of Drug Safety/PV experience in a global environment
  • Extensive working knowledge of MedDRA, safety databases (i.e.: ARGUS, ARISg) including case processing and quality review activities, Microsoft Office Suite (Word, Excel, PowerPoint)

The pay range that the Company reasonably expects to pay for this headquarters-based position is $163,000 - $191,000; 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.

If you are based in California, we encourage you to read this important information for California residents linked here.

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: https://www.corcept.com/

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.

 

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