Director, PV Operational Excellence

Viridian Therapeutics, Inc.; Waltham (MA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Competitive pay

Stock options

Medical, dental, vision

Disability coverage

401(k)

Employee stock purchase plan

Paid time off

Wellness programs

Job summary

Viridian Therapeutics, Inc. is seeking a Director, PV Operational Excellence based in Waltham, MA. This role leads PV quality programs across the product lifecycle and partners with QA and cross-functional teams to ensure regulatory compliance.

The position requires 12+ years in pharmacovigilance, an advanced life sciences degree, and deep knowledge of FDA/EMA/ICH guidelines, safety databases, and vendor oversight. Office-based with 3 days/week in the office. Competitive benefits.

Qualifications

• Requires 12+ years prior experience in pharmacovigilance.
• Advanced degree in a scientific discipline preferred.
• Demonstrated knowledge of FDA, EMA, ICH guidelines and safety reporting for clinical trials.

Responsibilities

• Develop strategy for defining and implementing quality/compliance programs across the global PV system.
• Lead processes to manage PV quality issues and CAPAs.
• Support late case investigation process design and implementation.
• Lead development and communication of PV quality indicators.
• Collaborate with PV leadership to ensure cross-functional PV compliance.
• Lead inspection readiness activities at the function level.
• Collaborate with QA on pharmacovigilance regulatory intelligence.
• Collaborate with QA on departmental training and compliance requirements.
• Provide strategic direction and global oversight of PV quality initiatives.
• Oversee outsourced hosted safety databases with QA IT.

Skills

Pharmacovigilance

Education

Advanced degree in life sciences

Tools

Argus/ArisG/Veeva Safety

Job 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 Director, PV Operational Excellence will be responsible for the quality oversight of the Pharmacovigilance activities throughout the products lifecycle, and will work closely with the department’s leadership team, all departmental subfunctions, and cross-functionally to ensure all PV activities are conducted in compliance with regulatory requirements, Viridian Quality Management System, and established internal procedures. The Director, PV Operational Excellence will partner with area subject matter experts (SMEs) to ensure vendor oversight, appropriate governance and compliance monitoring and communication. The Director will strive to build and maintain a quality mindset across Pharmacovigilance and ensure ongoing inspection readiness.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Develop the strategy for defining and implementing the applicable quality and compliance programs to ensure compliance across the global Viridian pharmacovigilance system
• Lead the development of processes to effectively manage PV quality issues and CAPAs
• Support the designs and implementation of a process for late case investigation
• Lead the build, review and communication of key quality and compliance indicators across the PV system.
• Collaborate with Pharmacovigilance and cross-functional leadership to ensure compliance with all aspects of the PV system
• Lead inspection readiness activities at the function level to ensure ongoing readiness
• Collaborate with Quality Assurance on PV regulatory intelligence activities
• Collaborate with Quality Assurance on departmental training activities, including setting training requirements and training compliance for Pharmacovigilance
• Provide dynamic leadership, strategic direction and global oversight of Pharmacovigilance quality initiatives
• Collaborate with QA Computerized Systems Validation and IT to provide oversight for outsourced hosted safety databases

Qualifications:

• Requires 12+ years prior experience in pharmacovigilance
• Advanced degree in a scientific discipline (e.g., PharmD, MD, PhD) preferred
• 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
• Medical, dental, and vision insurance
• 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 fertility, mental, financial, and proactive physical health programs

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.