- Perform oversight tasks of daily study-specific activities including case processing, SAE reconciliation, study set up, query management, eTMF filing, etc.
- Provide input into and medical review of vendor's narratives for quality and completeness and ensure timely submission of expedited reports
- Represent PV on program/study teams. Liaise with cross-functional personnel to provide advice on safety-related matters to ensure overall compliance and application of appropriate standards and methodologies for safety data collection activities for company sponsored studies
- Facilitate and lead cross-functional safety data review meetings; includes setting agenda, coordinating materials, data presentation, and documentation
- Review and update or develop (as needed) Safety Management Plans and other Safety level documents related to product safety. Ensure that the activities of these plans are being met
- Lead effective vendor management strategies to proactively identify operational risks and issues and ensure inspection ready documentation of oversight. Assist with study specific inspection and audit requests related to PV Operations
- Review and provide PV input for development of protocols, IBs, ICFs, CSRs, and other relevant study documents
- Lead authoring for aggregate safety reports (e.g., DSURs)
- Lead efforts related to ad hoc and routine signal evaluation
- Ensure identified quality and compliance metrics are being met and work closely with company Quality department to identify and manage quality issues related to PV
- Draft, contribute to, and maintain the PV departmental SOPs, policies, and work instructions as applicable
- Other duties as assigned
- Bachelor's level degree in nursing, pharmacy, or other health care related field
- 8+ years in pharmacovigilance/drug safety experience in the pharmaceutical/biotech industry setting
- Experience in both PV Operations and PV analytical work (e.g., signaling, aggregate report authoring)
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical/pharmaceutical information
- Experience with investigational drug safety is desirable
- Experience with gene therapy and/or mRNA products is a plus
- Thorough understanding of the drug development process and context applicable to safety surveillance activities in clinical trials
- Independently motivated, detail oriented, and excellent problem-solving ability
- Experience with vendor management
- Strong understanding of all relevant global PV regulations and global industry practices
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Director, Pharmacovigilance Scientist - Boston, United States - Verve Therapeutics Inc
Description
The PositionVerve is seeking a director level pharmacovigilance (PV) Scientist.
This is an individual contributor role and an exciting opportunity to be on the ground floor of a developing PV department working on cutting-edge therapies.
This role will provide day-to-day oversight of safety monitoring activities and safety operations as well as management of outsourced PV activities.
This individual will be partnering with cross-functional teams by providing PV guidance for clinical trials across Verve's growing gene editing pipeline.
The individual will be responsible for PV Operations as well as PV analytical work.Job Responsibilities
