Job Description
About 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 - Bachelor’s degree, preferably in a science or health-related field; master’s or professional degree a plus.
- A minimum of 10 years of direct experience in Pharmacovigilance/Drug Safety/Risk Management at a biopharmaceutical company or contract research organization.
- Strong working knowledge of global PV requirements (e.g., US Code of Federal [CFR] regulations, European Union [EU] Volume 10 clinical trials directive, Guideline on Good Pharmacovigilance Practices [GVP], and ICH Guidelines) is required.
- Strong knowledge of MedDRA and WHODrug terminology and its application are required.
- Proficiency and experience using validated global safety databases (e.g., Oracle Argus, ArisGlobal, etc.) and standard desktop computing programs.
- Expertise in PV regulations and implementation of PV processes.
- Experience with Health Authority Inspection interviews/process and management.
- Strong communication and ability to partner closely and effectively cross-functionally and cross-regionally.
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence greater outcomes.
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders to develop relevant and realistic plans, programs, and recommendations.
- Excellent analytical skills and an ability to communicate complex issues in a simple way and propose solutions.
- Ability to manage multiple, complex projects in a fast-paced environment.
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.)
Job Tags
Contract work, Local area,