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Head of Safety Operations (Director)

Employer
Corcept Therapeutics
Location
Menlo Park, California
Start date
Nov 19, 2021

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Discipline
Administration, Clinical, Manufacturing & Production
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay
The Head of Safety Operations will be responsible for all operational aspects of adverse event collection, processing and reporting, including working with the Head of Safety and others to support all Corcept products (investigational and marketed). You will set up Corcept global safety database and maintain and improve pharmacovigilance (PV) systems and processes to support case management, regulatory submissions, safety data exchange agreements and vendor management. This role will contribute to regulatory inspection and audits and continuous PV process improvement.

Essential Duties/Tasks
    Responsible for safety vendor oversight and maintenance of study-specific safety management plans for all programs.  Oversee AE collection, processing, reconciliation, and reporting.   Prepare safety reporting agreements for investigator-initiated studies and safety data exchange agreements.  Establish a global safety database to support pipeline expansion and product approvals. Prepare and maintain safety and PV policies and SOPs and ensure appropriate training. Support PV knowledge transfer and business continuity.  Support medical safety team regarding signal detection and validation, as well as submission of aggregate safety reports. Incorporate safety operational insights into study documents and regulatory reports. Participate in development and management of departmental budget.
Preferred Education and Experience
    RN, PharmD or MSc/PhD in a biological science.  Knowledge in oncology, endocrinology, metabolism and neurology a plus. Vendor management experience.  Expertise with Argus (or similar), MedDRA and WHO Drug coding dictionaries. Minimum eight-years in safety and PV experience, including three-years functional leadership experience. Other relevant experience may be considered.
Preferred Skills Qualifications, or Technical Proficiencies
    Excellent communication skills (verbal and written); strong collaborator Being proactive. Good problem-solving and project management skills. Comfortable with ambiguity, yet self-motivated and timeline driven

 

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