Senior Director/Executive Director, Drug Safety and Pharmacovigilance
Our client is a clinical-stage biotechnology company. They have asked us to assist them in a search for a Senior Director/Executive Director, Drug Safety and Pharmacovigilance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance.
- Performs signal detection activities to ensure signal identification and evaluation.
- Authors or contributes 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.
- Reviews and summarizes scientific literature relevant to pharmacovigilance on assigned projects.
- Is responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs), as well as expedited safety reporting.
- Supports quality management function to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA.
- Provides 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.
- Stays current with international pharmacovigilance requirements and guidelines.
- Serves as point of contact for cross functional development teams and is involved in all safety surveillance activities.
- Represents the DSPV function under Clinical Research at applicable leadership team meetings.
- Attends required inter-departmental and project team meetings.
- Ensures timely communication and exchange of information with the Clinical Research and Operations teams.
- Coordinates cross-functionally on inspection readiness and ensure team inspection readiness.
- Performs review of adverse event reports ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment. Generates Analysis of Similar Events.
- Ensures all required trainings are completed for self and the team within assigned timelines.
- Leads quarterly Drug Safety Advisory Committee meetings and oversees Adverse Event and safety review and coding of the ongoing programs.
- Leads and coordinates all DSMB meetings.
- Ensures the DSPV Database supports the department needs. Provides oversight of systems and MedDRA updates in collaboration with the relevant DSPV vendor.
- Leads exchange of safety data with partners, as required.
- A Medical degree is required.
- Requires a minimum of 12 years of experience working in a pharmaceutical/biotech environment.
- Must have at least five years of pharmacovigilance experience in drug development pharma/biotech industry.
- A minimum 3 years in managerial role in drug safety is required. A minimum three years managing contracted PV vendors is preferred.
- Experience with FDA and other regulatory agencies working with regulatory groups is preferred.
- Previous experience with risk mitigation strategies is preferred.
- Requires the demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department.
- A thorough knowledge and experience in all aspects of safety reporting for clinical trials is required.
- Operational expertise with ARGUS is preferred.
- Experience specific to Ophthalmology/Gene therapy is preferred but not required.
- Must have 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.
- Must be able to work across therapeutic areas and functions.
- Requires the ability to works collaboratively.
- Must be committed to investing in long-term development of others.
- Must have strong analytical and problem-solving skills with superb attention to detail.
- Requires strong verbal, written technical communication and presentation skills.
- Must be proficient with Microsoft Word, Excel, PowerPoint.
- Supervisory experience is preferred.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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