Job Description

Job Description

Job Description

The Company

Verve Therapeutics is a biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, the company aims to develop transformative, once-and-done therapies for coronary heart disease. Verve's gene editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels. The company is advancing a pipeline of precision genetic medicines, led by VERVE-101, which is being developed initially for heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease. In 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.

Verve 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.

• 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

EEO Statement

Verve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Verve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.

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