What are the responsibilities and job description for the Pharmacovigilance Director position at Meet?
About the Job
Our client, a clinical-stage biopharmaceutical company based in San Fran Bay Area, California, is focused on developing novel therapeutics for the treatment of rare diseases. The company is driven by the unique and multi-faceted needs of the community they serve. Their team is made up of exceptional individuals working together to deliver meaningful outcomes for those living with these rare conditions.
They are currently searching for an experienced Director of Pharmacovigilance (PV) to provide direct, hands-on pharmacovigilance support and manage vendors, business partners, and individuals involved with Individual Case Safety Report (ICSR) processing to ensure efficiency, quality, and compliance with internal procedures and global regulations. The individual will manage global safety database activities, including serious adverse event reporting metrics, support clinical study teams, and contribute to risk management and pharmacovigilance activities for clinical stage and commercially marketed products. Additionally, the role will involve leading process improvements and implementing solutions related to pharmacovigilance and ICSR reporting.
Responsibilities :
- Review and evaluate individual and aggregate adverse event (AE) reports for potential drug safety-related issues and provide recommendations when potential issues are identified.
- Manage PV vendors / providers to ensure they fulfill their responsibilities.
- Serve as Subject Matter Expert (SME) for processing Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for clinical-stage and marketed products.
- Ensure AEs from spontaneous reports, solicited reports, and literature cases are handled in compliance with global regulatory requirements and company policies.
- Review, update, and / or author SOPs related to PV to ensure compliance with FDA, EMA, ICH, and other applicable regulatory guidelines.
- Facilitate communication with departments involved in receiving, investigating, or reporting AEs.
- Collaborate with other departments or corporate initiatives to provide PV guidance and support.
- Handle AE and product complaint (PC) training both internally and with global vendors / partners.
- Lead or participate in initiatives to enhance PV process effectiveness by gathering, analyzing, and communicating performance metrics.
- Collaborate with corporate partners to ensure the exchange of drug safety-related data.
Qualifications :
