Director, PV Operational Excellence

Responsibilities

• 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
• Elevate a quality mindset across Pharmacovigilance
• 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)
• 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
• Able 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.)
• Able to travel up to 10-15%

Pay & Benefits

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision insurance
• 100% Paid Parental Leave
• 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
• Variety of 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.