Remote PV Associate Director – Quality

Civica Rx; United States; À distance; USD 180 000 - 210 000; Plein temps

Résumé du poste

Civica, Inc. is seeking a remote QA Associate Director, Pharmacovigilance with a decade of PV/Safety leadership experience to guide its pharmacovigilance program across products.

You will lead quality systems, manage vendor relationships, and support regulatory inspections from a remote location. The role emphasizes continuous process improvement, strategic planning, and effective communication with senior management and cross-functional teams.

Qualifications

• Degree in a health care profession such as BSN, RN, PharmD, PA, DO, MD.
• Over ten (10) years of experience 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 pharmacovigilance quality management systems including investigation of deviations, CAPA, and change controls.
• Demonstrated understanding of GXP requirements for compliance with domestic and international regulations including those of the US FDA and other applicable agencies in biologics, oral solid dosage product and/or combination products.

Responsabilités

• Lead Civica pharmacovigilance function including but not limited to: ensuring compliance with regulations and best practices.
• Oversee third party call center for intake and triage of AE, PQC, and Medical Inquiries.
• Establish quality checks for AE case intake, triage, data entry, medical assessment, seriousness/causality assessment, and regulatory submissions.
• Oversee case processing for adverse events where Civica is MAA holder.
• Lead PV activities for new product introduction or discontinuation.
• Support safety signal evaluation, benefit-risk assessment and safety-related decision making.
• Provide QA support for inspection preparation and hosting pharmacovigilance regulatory inspections.

Connaissances

Leadership

Cross-functional collaboration

Regulatory compliance

Quality systems

Communication

Problem solving

Formation

BSN

RN

PharmD

Description du poste

Civica, Inc. is seeking a remote QA Associate Director, Pharmacovigilance with a decade of PV/Safety leadership experience to guide its pharmacovigilance program across products.

You will lead quality systems, manage vendor relationships, and support regulatory inspections from a remote location. The role emphasizes continuous process improvement, strategic planning, and effective communication with senior management and cross-functional teams.