Director, Pharmacovigilance Operations

Job not on LinkedIn

🔥 7 minutes ago

🇺🇸 United States – Remote

💵 $205k - $240k / year

⏰ Full Time

🔴 Lead

⚙️ Operations

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MapLight Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

MapLight Therapeutics, Inc. is a biotechnology company dedicated to transforming the treatment of brain disorders, including conditions such as schizophrenia, Alzheimer’s disease, and autism spectrum disorder. They leverage advanced technologies like optogenetics and transcriptomics to identify specific neural circuits involved in these disorders, aiming to develop targeted therapeutics with the potential to significantly improve patient outcomes. Their innovative discovery platform supports a robust pipeline of clinical and preclinical trials focused on addressing significant unmet medical needs in central nervous system conditions.

📋 Description

• Develop strategy for PV operations and support PV Head in implementing strategy and vision for the PV function • Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting • Manage implementation of the MPLT safety system, including safety database and processes, for regulatory-compliant ICSR case processing • Oversee PV vendor and contract management, including third-party CROs and partners • Oversee safety-related alliance management, including SDEAs • Manage information and data flow between clinical and PV vendors in collaboration with Clinical Operations • Oversee quality and compliance for ICSR case processing and reporting KPIs • Develop, contribute to, review, and maintain current ICSR case-processing SOPs, forms, and SMPs • Liaise with safety surveillance and cross-functional teams to support timely dissemination of safety deliverables • Collaborate with Quality and lead PV contributions for audits and inspections • Manage PV functional deliverables and projects • Oversee PV functional contributions to TMFs • Manage PV budget and vendor resources • Coach and mentor PV Operations associates • Report to the Vice President, Pharmacovigilance

🎯 Requirements

• Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science • Minimum 8 years of pharmacovigilance experience within the biopharmaceutical industry, with at least 3 years in leading PV operations • Competence in conducting safety data reviews, vendor management, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post marketed products • Experience with MedDRA and drug coding reviews • Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes • Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections • Demonstrated PV project management skills in a fast-paced organization • Exceptional communication and cross-functional collaboration skills • Strategic thinking and ability to translate complex safety data into actionable insights for regulatory and clinical decision-making • Ability to work within a growing organization and help the organization evolve over time • Ability to engage in open, constructive and continuous dialogue with company stakeholders based on equality and mutual respect • Highly motivated, self-driven and dependable • Committed to MapLight's Core Beliefs and Values • Ability to travel as needed, up to 10%, for corporate and departmental meetings

🏖️ Benefits

• Annual bonus opportunity • Medical insurance • Dental insurance • Vision insurance • Life insurance • AD&D insurance • Short-term disability • Long-term disability • 401(K) plan with match • Stock options • Flexible non-accrual paid time off • Parental leave • Ability to travel as needed (up to 10%) for corporate and departmental meetings