Description

At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Senior Director, PV Operations, the Associate Director, Global PV Intake will be responsible for overseeing and managing the strategy and standards setting in the area of PV intake in the Post-Marketing space (non-clinical) globally, ensuring consistent implementation and compliance with regulatory requirements, and collaborating cross-functionally with Commercial, Medical Affairs, and others to ensure tracking and ongoing management of sources of safety data as  part of the global PV system.

This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management. 

Responsibilities (including, but not limited to):

• Oversee the gathering and intake of post-marketing safety reports globally
• Set PV operation strategy and establish safety report intake standards and processes for the collection of Post-Marketing (non-clinical) safety reports from all sources globally.
• Oversee the development, maintenance and implementation of:
  • Controlled documents (SOPs), data handling conventions and other process documents for safety report collection
  • Safety operational content and processes for tools for Post-Marketing safety report intake such as AE forms and/ or electronic data capture system
  • Database requirements and configurations to enable safety-related activities
  • Training requirements and materials for Post-Marketing safety report intake
  • Metrics and KPIs for Post-Marketing safety report intake
• Lead the following partner / vendor oversight activities, in conjunction with relevant functions (such as Medical Affairs and Commercial), in relation to Post-Marketing safety report intake
  • Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight plans)
  • Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)
  • Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)
  • Conduct partner oversight and performance management on AE intake work (e.g., monitoring reports, quality evaluations, annual meetings)
• Communicate on PV legislation and regulatory commitments across the organization and externally
• Acts as subject matter expert on Pharmacovigilance (PV) operations for the Post-Marketing space (non-clinical) during audits / inspections

Requirements

• Requires 10+ years prior experience in pharmacovigilance
• Advanced degree in a scientific discipline (e.g., PharmD, MD, PhD) preferred. Minimum Bachelor’s degree required.
• Demonstrated knowledge of relevant FDA, EMA, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments
• Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus/ArisG/Veeva Safety)
• Development and review of SOPs and Work Instructions
• Vendor Management oversight responsibilities required. Experience with setting up a post-marketing PV vendor and global safety database preferred
• Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities
• Excellent verbal and written communication skills including the ability to present to both internal and external partners
• Strong analytical and problem-solving skills
• Ability to work effectively in a fast-paced, dynamic environment
• High integrity and commitment to patient safety
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 10-15%
• The salary range for this position is commensurate with experience
   

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Competitive medical, dental, and vision coverage 
• Fertility and mental health programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian
   

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.