Director/Senior Director Drug Safety Pharmacovigilance Physician

Job Title
Director/Senior Director Drug Safety Pharmacovigilance Physician
Job ID
Work Remote
Remote, East Coast - USA, 
Other Location
Work Location and Classification
Remote, East Coast - USA

The Director/Senior Director, Drug Safety and Pharmacovigilance (DSPV) Physician 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 expe​​​rience 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 Global VP, Clinical Development, or designee.

Duties and Responsibilities
• Oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance
• 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 DSPV at leadership team meetings
• Authoring risk management plans, DSURs, CSR, ICSFs, IBs; Regulatory Authority inspection experience, IND, NDA, BLA/NDA
• Coordinate cross-functionally, on inspection readiness and ensure team inspection readiness
• Review 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
• Lead and coordinate all DSMB and/ or Safety Advisory Committee meetings.
• 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.
• Assist in overseeing medical monitoring to clinical studies.
• Participates in clinical/medical advisory panels and investigator meetings.
• Contributes as author and provides clinical review of protocols, clinical study reports, publications, core safety information, labels, and regulatory reports with focus on providing overview for the medical analysis and safety sections
• Remains up to date with current information on regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
• Represents the company in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas as needed.
• Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
• Accountable for the adherence to Good Clinical Practice, data integrity principles and other key AGTC policy requirements by external and contract partners
• Other duties as assigned
• This job description is subject to change at any time

Educational Qualifications
• Medical degree (e.g., MD/MBBS)

Additional Qualifications
• Director: minimum of eight (8) years’ experience working in a Pharmaceutical / Biotech environment and 3+ years of pharmacovigilance experience in drug development pharma/biotech industry.
• Senior Director: minimum of ten (10) years’ experience working in a Pharmaceutical / Biotech environment and 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 preferred
• Experience specific to Ophthalmology/Gene therapy preferred
• 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
• 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
• 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, Outlook, Word, Excel, PowerPoint and Zoom

Physical Requirements
• Physical demands: (check one)
☒ sedentary (< 10 lbs.)
☐ light work (< 20 lbs.)
☐ medium work (< 50 lbs.)
☐ heavy work (< 100 lbs.)
☐ very heavy work (>100lbs.)
• Physical activity: (check all that apply)
☒repetitive motion
☐ balancing
☒ typing/grasping
• Visual acuity: analyzing data, reading, writing
• Working conditions: indoor office environment

Supervisor Responsibilities
• Supervisory experience preferred

Option 1: Create a New Profile

Visionary science for life changing cures.