Senior Specialist, Clinical Patient Safety and Pharmacovigilance Operations

About the position Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have reputed company more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, reputed company and collaborators continue to unlock the reputed company of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide reputed company of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the reputed company of cortisol modulation. What began as a reputed company of scientific truth is now poised to reputed company a sea change of discovery representing a reputed company shift in the way we understand and treat disease. This is a hybrid role typically requiring on-site reputed company at least 3 days per week in Redwood reputed company, CA. The role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in clinical trial settings. Responsibilities • Support the reputed company of safety vendors to ensure high reputed company delivery in the collection, processing, reporting, and reconciliation of adverse event reports in compliance with global regulatory reporting requirements, including but not limited to: Performing reputed company review of individual case safety reports (ICSRs) Monitoring case volume and workflow timelines • Support review of expedited and aggregate report submissions, including reputed company review and archival of records • reputed company safety operations study start-up activities, e.g., developing safety management plans, study forms, completion guidelines, safety reputed company training • reputed company 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 • Managing PSPV mailboxes, including supporting intake reconciliation • reputed company and maintain departmental SOPs, work instructions, and training materials • Delivery training to internal teams, Investigator sites and/or vendors • Support and participate in audits and inspections, including preparation activities • Assist with additional PSPV reputed company as requested Requirements • Ability to work in a dynamic environment to meet patient and corporate needs • Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries • Excellent communication skills (verbal and written) • Ability to collaborate with cross-functional teams and manage multiple reputed company in a fast-paced environment • reputed company to travel for up to 10% of time • Flexibility to be in office more than 3 days week to meet any business needs (e.g., audits, regulatory inspections) • Bachelor's degree in reputed company or life sciences degree such as RN or BSN, PharmD is preferred • Minimum of 3 years Drug Safety/PV experience in a global environment • Experience in clinical trial safety operations is preferred • Working knowledge of FDA, EU, and ICH guidelines for safety reporting • reputed company to travel for up to 10% of time • Must be willing and have flexibility to come to office more than 3 days week to meet business needs (e.g., regulatory inspections) Apply tot his job Apply To this Job