Director, Drug Safety/PV Operations

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Director, Drug Safety/PV Operations

The PV Operations Lead manages PV activities globally across all AVROBIO products in clinical development and on the market. Specifically, the Operations lead (1) supports operational aspects of the PV system, (2) collaborates with cross-functional partners to facilitate the development of comprehensive plans, and (3) coordinates the execution of safety deliverables. The PV operations lead is also responsible for (4) project management support and coordinating achievement of PV deliverables, (5) providing input to ensure alignment of global regulatory and safety plans cross-functionally, and (6) project management support for process improvement initiatives.

Cambridge
Medical
Feb 25 2021
Key Responsibilities
  • Provide vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics
  • Support management of Safety governance meetings
  • Work with PV Leads on safety related deliverables, including facilitation of Safety governance meetings and Global Safety Team meetings, tracking of safety deliverables, and management of safety reports and documents
  • Assume leadership role for creation of departmental standard operating procedures, working practices, and best practices in project management
  • Maintain knowledge of product safety deliverables and provide comprehensive reports and dashboards summarizing each products current and future PV activities
  • Identify and create communication and issue identification / resolution plans and manage timelines for PV deliverables
  • Ensure that the PV Database supports the department needs, including specific workflows and reporting / querying functionalities
  • Monitor and confirm data accuracy in safety systems for key deliverables
  • Facilitate PV meeting planning, slide preparation, meeting attendance, and follow-up on action items
  • Organize and oversee the receipt, evaluation, processing, documentation and reporting of adverse event information from clinical trials, investigator sponsored trials, post-marketing, etc. sources
  • Manage and oversee PV vendors. Monitor performance and compliance
  • Support ongoing safety surveillance of company products
  • Contribute to regulatory submissions, aggregate reports, investigator communications, labeling, etc. as needed
  • Develop and implement PV training programs for internal and external needs and monitor compliance
  • Provide safety and pharmacovigilance expertise in-house for products in development and marketed products
  • Oversee preparation and quality control activities for safety case processing activities performed internally and by vendors or contractors
  • Lead development of standard operating procedures for safety and internal compliance
  • Manage license partners, vendors, etc. with PV Agreements and Safety Data Exchange Agreements
  • Liaise with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, and Legal
  • Support the Head of Pharmacovigilance develop and implement appropriate drug safety programs and processes
  • Support preparation and review of aggregate reports
  • Review and provide feedback for Safety Management Plans
Minimum Requirements/ Qualifications
  • Pharmacist/PharmD or Bachelor’s degree in the life sciences or related area or Masters in Nursing with a minimum of 3 years of clinical experience
  • Minimum 7 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance.
  • At least 2 years in a leadership role with at least 2 years of people management.
  • Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
  • Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
  • Working knowledge and experience with European pharmacovigilance regulations preferred.
  • Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review and regulatory submission, issuing follow up queries, etc.
  • Demonstrated technical, administrative, and project management capabilities.
  • Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
  • Adaptable to changing priorities.
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer