Director – Pharmacovigilance Scientist
Posted on 3/20/2024
Verve Therapeutics

201-500 employees

Develops gene editing therapies for heart disease
Company Overview
Verve Therapeutics, a clinical-stage biotechnology company, is a leading player in the fight against heart disease, leveraging its expertise in cardiovascular medicine, human genetics, and gene editing to develop transformative, once-and-done therapies. The company's unique approach to gene editing, designed to permanently lower LDL cholesterol and triglyceride levels, sets it apart from competitors and positions it at the forefront of precision genetic medicine. With a culture that fosters passion and drive, Verve has been recognized as a "Best Places to Work" by the Boston Globe, demonstrating its commitment to both its mission and its employees.
Biotechnology

Company Stage

N/A

Total Funding

$419.3M

Founded

2018

Headquarters

Boston, Massachusetts

Growth & Insights
Headcount

6 month growth

3%

1 year growth

15%

2 year growth

94%
Locations
Cambridge, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
CategoriesNew
Medical, Clinical & Veterinary
Diagnostics & Laboratory Professionals
Healthcare Administration & Support
Requirements
  • 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 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
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