Job: Head of Pharmacovigilance, Precision BioSciences, Durham, NC
Head of Pharmacovigilance
Durham, NC 27701 United States
Precision BioSciences is seeking a Head of Pharmacovigilance who will be responsible for the overall accountability for Pharmacovigilance (PV) at Precision Biosciences (PBI). The Head of PV will be responsible for the creation of and management of PBI’s PV system including creation, oversight, and maintenance of PV SOPs internally; and creation, oversight, and maintenance of SOPs for external vendors related to medical monitoring and reporting. This role will require close interaction with other groups and departments within PBI (Clinical Operations, Biostatistics, Data Management, Regulatory, QA, Research, Commercial).
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
Act as single contact point for Competent Authorities on a 24/7 basis and in case of inspections, as well as act as medical representative for PBI, e. g. in meetings with regulatory agencies
Line management of the Pharmacovigilance group (currently no direct reports, expected to hire)
Establish/maintain the PV department infrastructure (such as in-house PV database, expedited adverse event reporting to US and European regulatory authorities including medical assessment of individual ADR cases, SOPs)
Maintain and manage PBI’s PV system, including set up of the Pharmacovigilance Master File as mandated by current regulatory guidance
Oversight and responsibility of safety profiles and any emerging safety concerns in relation to medicinal products for which PBI is responsible
Ensure provision of any information necessary for the evaluation of the benefits and risks of PBI’s medicinal products to Competent Authorities
Responsibility for PV (including SAE workflow, processing and reporting) in PBI’s clinical trials and for expedited adverse event reporting to US and European regulatory authorities including medical assessment of individual ADR cases
Monitor compliance, e. g. for reporting to regulators as for time and quality
Responsible for safety-relevant sections in clinical development programs and clinical study protocols
Create PV related documents, including risk benefit assessments, risk management plans, and core safety information documents
Responsible for creation and distribution of periodic reports and reports of post-authorisation safety studies
Contribute to Investigator Brochures, Statistical Analysis Plans, Clinical Study Reports
Responsible for policy documents and processes relevant to PV and Clinical Safety Data Management
Collaborate with QA to establish and maintain an adequate quality management system for pharmacovigilance
Contribute to publication of clinical study results
Serve as primary PBI contact to independent Data Safety Monitoring Boards
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
Medical Doctor, Physician’s Assistant, Nurse Practitioner, or Pharmacist with approximately 10 years’ experience working in Pharmacovigilance in the biotechnology/pharmaceutical industry; years of experience may be less important than breadth and depth of experience in some cases
Extensive experience interacting with regulatory agencies, particularly US (FDA) and ideally Europe (EMA)
Knowledge of international laws, regulations and policies governing Pharmacovigilance
Experience with oncology, cell therapy, and/or in vivo gene editing would be beneficial
Excellent command of English with strong written and oral skills, including experience in medical and regulatory terminology (MedDRA)
Highly self-motivated, conscientious, meticulous individual able to work with a minimum of supervision
Team player who enjoys establishing and maintaining good working relationships
In-depth knowledge and skills in use of database applications, MS Office and other relevant software
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