DescriptionReporting 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
- Elevate a quality mindset across Pharmacovigilance
- Collaborate with QA Computerized Systems Validation and IT to provide oversight for outsourced hosted safety databases
Requirements- 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
• 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
• Various fertility, mental, financial, and proactive physical health programs
