Sr. Manager, Drug Safety Operations

Corcept is engaged in the discovery and development of drugs that treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym^® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity.

In addition to our commercial product, Korlym, we have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer, weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis (“NASH”).  We are about to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (“ALS”).

In 2021, we generated revenue of $366 million and net income of $112 million.

Sr. Manager, Drug Safety Operations

We are looking for an experienced Sr. Manager, Drug Safety Operations who will provide technical and process-related support for clinical trials and post marketed report processing. 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 Director & Head, 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, operations, and compliance.  Maintains positive relationships with all Corcept personnel involved in Safety to ensure compliance and will participate in other Safety-related activities as needed.

Responsibilities:

• Vendor oversight activities for assigned products. Address any case-processing related queries during vendor/partner reconciliation
• Operational management activities for onshore teams and vendors, including but not limited to workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of Individual Case Safety Reports (ICSRs).
• Ensures all cases meeting regulatory reporting are submitted to regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, SMPs, SOPs and applicable regulations.
• Supports the development and implementation of drug safety& PV process improvements, tools, systems, and procedures to enable excellence and consistency in PV activities in collaboration with other stakeholders
• Reviews regulatory reports required for ICSR submissions. Support root cause analysis for deviations /CAPAs as applicable
• Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases and reviewing to ensure high quality data capture in the databases
• Develops and implements Safety Management Plans (SMPs)
• Manages relationships with internal and external vendors, as the safety contact, supporting safety reporting to ensure that compliance and safety reporting requests are being met, including participation in periodic audits, and contributing to the development of correction plans
• Provide operational support for the timely development of safety-related regulatory documentation including DSURs, IND annual reports, or other global reports and assist in the responses to questions from regulatory agency or IRB/EC on safety related issues
• Quality control of documents submitted to the TMF by PV service provider
• Assists in the management of pharmacovigilance audits and inspections                                                   

Preferred Skills, Qualifications and Technical Proficiencies:

• Working knowledge of FDA guidelines for clinical drug safety surveillance and post-marketing safety regulations
• Strong verbal, written, and interpersonal communication skills including ability to develop and deliver presentations
• Strong organizational, project management, technical and problem-solving skills, and ability to develop business solutions to complex problems
• Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge
• Able to work independently and collaboratively in a multidisciplinary team
• Able to occasionally work extended and/or flexible schedule to meet client requirements
• Proficient computer knowledge and computer keyboarding skills including intermediate proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
• Strong skills in the management of safety information originating from both clinical development and post-marketing sources
• Demonstrated experience in managing business processes outsourcing vendors and relationships

Preferred Education and Experience:

• Bachelor’s degree in life sciences and minimum 7 years experience in biopharmaceutical industry or clinical research organization in safety operations.
• RN, RPh, PharmD is a plus
• Extensive working knowledge of MedDRA, Clinical Databases (e.g., RAVE), Medidata, safety databases (i.e.: ARGUS, ARISg), Microsoft Office Suite (Word, Excel, PowerPoint)

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