Director – Pharmacovigilance Scientist @ Verve Therapeutics

The Company

Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. 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.

The Position

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.

Job Responsibilities

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

Qualifications

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

Don’t check off every box in the requirements listed above? Please consider applying anyway. We want the best candidates for the job, and those candidates don’t always meet 100% of the qualifications listed. At Verve, we are dedicated to building diverse and inclusive teams who embody the values we share: grit, spirit, drive, and passion. We look forward to learning more about your unique background.

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.

Recruitment & Staffing Agencies

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.

The Company

The Position

Job Responsibilities

Qualifications

EEO Statement

Recruitment & Staffing Agencies

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