What are the responsibilities and job description for the Director, Pharmacovigilance position at Soleno Therapeutics Inc?
Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).
At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.
We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.
Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.
Summary of Job (brief description)
Soleno Therapeutics is searching for an experienced Director of Pharmacovigilance (PV) who will provide direct hands-on pharmacovigilance support and management of vendors, business partners, and individuals involved with Individual Case Safety Report (ICSR) processing to ensure efficiency, quality, and compliance with internal procedures and US / global regulations. This individual will manage the global safety database activities including serious adverse event reporting metrics, support clinical study teams, and support of risk management and pharmacovigilance activities for clinical stage and commercially marketed Soleno products. This individual will also lead in the planning, execution, and implementation of process improvements, procedures, and 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 of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for clinical-stage and marketed products.
- Ensure that AEs from spontaneous reports, solicited reports, and literature cases involving Soleno products are collected, analyzed, and handled in accordance with all global / local regulatory requirements and company policies.
- Review, update, and / or author SOPs related to PV to ensure their compliance with FDA, EMA, ICH, and other applicable regulatory guidelines.
- Facilitate and ensure communication with departments that may be involved with receiving, investigating, or reporting AEs.
- Collaborate with, and provide PV guidance and support for interdepartmental or corporate initiatives.
- Handle AE and product complaint (PC) training internally and globally to vendors / partners.
- Lead or participate in initiatives to enhance the effectiveness of PV processes by gathering, analyzing, and communicating relevant performance metrics.
- Collaborate with corporate partners to ensure exchange of drug safety-related data.
Qualifications
Salary Range : $230,000 - $260,000
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)
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Salary : $230,000 - $260,000
