Remote Senior Pharmacovigilance Leader

Civica Rx; Lehi (UT); À distance; USD 170 000 - 210 000; Plein temps

Résumé du poste

Civica, Inc. is seeking a remote QA Associate Director, Pharmacovigilance, to lead the pharmacovigilance program across the product portfolio.

You will ensure compliance with cGMP, SOPs, and regulatory standards for generics and biosimilars, including combination products, and guide adverse event processing and regulatory submissions. The role requires 10+ years in pharmacovigilance/safety, strong QA leadership, and experience with PV systems, CAPA, and inspection readiness.

Qualifications

• Degree in a health care profession (BSN, RN, NP, PharmD, PA, DO, MD).
• 10+ years in the pharmaceutical industry, preferably in Pharmacovigilance/Safety roles for marketed products.
• Experience establishing a PV program as Market Authorization Holder is a plus.
• 3–5 years of experience managing PV quality systems (investigation of deviations, CAPA, change controls).
• Understanding of GXP requirements for US FDA and international regulations in biologics, oral solids, or combination products.
• Strong interpersonal, verbal and written communication including technical writing.
• Ability to lead projects with minimal supervision.

Responsabilités

• Lead Civica pharmacovigilance function, ensuring regulatory compliance and best practices.
• Oversee third party call center for intake/triage of AE, PQC, and medical inquiries.
• Establish quality checks for case processing, data entry, medical assessment, and reporting.
• Manage PV activities for new product introduction or discontinuation.
• Support safety signal evaluation and benefit–risk assessments.
• Prepare for and host pharmacovigilance inspections and regulatory interactions.
• Manage vendor qualification and audits for PV and safety-related vendors.

Description du poste

Civica, Inc. is seeking a remote QA Associate Director, Pharmacovigilance, to lead the pharmacovigilance program across the product portfolio.

You will ensure compliance with cGMP, SOPs, and regulatory standards for generics and biosimilars, including combination products, and guide adverse event processing and regulatory submissions. The role requires 10+ years in pharmacovigilance/safety, strong QA leadership, and experience with PV systems, CAPA, and inspection readiness.