Director, Drug Safety & Pharmacovigilance

AGTC in Gainesville, FL

  • Industry: Pharmaceutical/Biotechnology - Medical Affairs
  • Type: Full Time
  • Compensation: $95,960.00 - 202,330.00 / Year*
position filled
Mission

The Director, Drug Safety and Pharmacovigilance (DSPV) position requires in-depth subject matter expertise, strong operational strategic thinking and leadership skills to effectively manage safety and global pharmacovigilance resulting in regulatory controlled deliverables to both internal and external partners. This includes knowledge of global regulatory requirements for adverse event reporting, relevant experience in medical review, signal detection, risk management, and benefit-risk assessment in the context of aggregate reports (DSUR).

Reporting Relationship
  • This position will report to the VP, Clinical Research and Medical Affairs.

Duties and Responsibilities
  • Oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance
  • Perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all AGTC investigational products
  • Author or contribute to safety sections of clinical investigator brochures, protocols, inform consent forms, CSRs, integrated summaries of safety, core safety information, labels and regulatory reports with focus on providing overview for the medical analysis and safety sections
  • Review and summarize scientific literature relevant to pharmacovigilance on assigned projects
  • Responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs), as well as expedited safety reporting
  • Support quality management function to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA
  • Provide expertise on DSPV operational processes to the Clinical Research and Medical Affairs teams, the Clinical Development Operations team, the Regulatory Affairs team plus other stakeholders as required
  • Stay current with international pharmacovigilance requirements and guidelines
  • Serve as point of contact for cross functional development teams and is involved in all safety surveillance activities, including safety review of individual safety cases, signal detection/evaluation and risk management activities
  • Represent the AGTC DSPV function under Clinical Research at applicable AGTC leadership team meetings
  • Attend required inter-departmental and project team meetings
  • Authoring risk management plans, DSURs; safety input/review of clinical protocols, CSR, ICSFs, IBs; Regulatory Authority inspection experience, IND, NDA
  • Ensure timely communication and exchange of information with the Clinical Research and Operations teams
  • Coordinate with AGTC cross-functionally, on inspection readiness and ensure team inspection readiness
  • Perform review of adverse event reports including but not limited to all Serious Adverse Events, Events of interest, and expedited individual case safety reports ensuring that appropriate interpretation, consistency and quality are applied to adverse event case assessment. Generate Analysis of Similar Events
  • Ensure all AGTC required trainings are completed, for self and the team, within assigned timelines
  • Lead quarterly AGTC Drug Safety Advisory Committee meetings and oversee Adverse Event and safety review and coding of the ongoing programs
  • Will lead and coordinate all DSMB meetings
  • Ensure the DSPV Database supports the department needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant DSPV vendor
  • Exchange of safety data with partners, as required
  • Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review. Partner with Clinical Quality, to identify CAPAs required to address late reporting and maintain current PV regulatory intelligence in the company safety database
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.
  • Other duties, responsibilities and activities may change or be assigned at any time with or without notice

Educational Qualifications
  • Medical degree (e.g. MD/MBBS)
  • Minimum of 10 years' experience working in a Pharmaceutical / Biotech environment

Additional Qualifications
  • 5+ years of pharmacovigilance experience in drug development pharma/biotech industry;
  • Minimum 3 years in managerial role in drug safety; minimum 3 years managing contracted PV vendors preferred
  • Experience with FDA and other regulatory agencies working with regulatory groups preferred
  • Previous experience with risk mitigation strategies preferred.
  • Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
  • Thorough knowledge and experience in all aspects of safety reporting for clinical trials
  • Strong knowledge and experience with currently available drug safety database systems, electronic document management systems and QC tools. This also includes MedDRA and linked technologies
  • Operational expertise with ARGUS preferred
  • Experience specific to Ophthalmology/Gene therapy preferred but not required.
  • A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
  • Able to work across therapeutic areas and functions
  • Works collaboratively (establishes shared purpose across boundaries)
  • Develops people and the organization (invests in long-term development of others)
  • Strong analytical and problem-solving skills with superb attention to detail.
  • Strong verbal, written technical communication and presentation skills
  • Proficiency with Microsoft Word, Excel, PowerPoint

Physical Requirements
  • Physical demands:

? sedentary (
? light work (
? medium work (
? heavy work (
? very heavy work (> 100 lbs.)

  • Physical activity:

? repetitive motion

? balancing

?stooping

?lifting

?climbing

?kneeling/crouching

?crawling

?reaching

? standing

? typing/grasping

? walking

?pushing/pulling

? hearing

  • Visual acuity
  • Working conditions

Supervisor Responsibilities
  • Supervisory experience preferred

Associated topics: ad, alumni, care, chief marketing officer, demand generation, endowment, marketing, policy, principle gift, relationship

* Estimated salary


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