Director, PV Case Management

Viridian Therapeutics Inc. • Waltham, MA

52d • Hybrid

About The Position

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 Case Management will be responsible for the operational management and oversight of case processing activities performed internally and also externally by Pharmacovigilance's vendors, in both the post-marketing and clinical trials settings. The Director ensures compliance with regulatory requirements, corporate and departmental procedures and data handling conventions. 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.

Requirements

• Requires 12 years prior experience in pharmacovigilance
• 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%

Nice To Haves

• Advanced degree in a scientific discipline (e.g., PharmD, MD, PhD) preferred
• Experience with setting up a post-marketing PV vendor and global safety database preferred

Responsibilities

• Oversee ICSR workflow to ensure prioritization and high quality of cases, working closely within PV with PV Scientist, Safety MDs, and cross-functional colleagues in addition to vendor staff to ensure compliance with timelines and requirements
• Ensure compliance in AE case processing, in both the Post-Marketing and Clinical Trial settings
• Act as a subject matter expert on operations and oversight of AE case processing partners during audits and inspections as necessary
• Lead PV vendor management including business requirements knowledge, vendor selection, contract details, vendor oversight, and safety management plans as needed
• Lead vendor onboarding and ongoing management of partner and vendor needs (e.g., access, training, etc.)
• Set case handling standards and perform relevant case handling activities as needed, e.g. retrospective QC and approving logical deletions
• Complete late case investigations and owning case management related CAPAs
• Act as the business lead for the safety database needs
• Lead safety CT operational activities, including SAE data reporting and reconciliation between the safety and clinical databases
• Review Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation Plans
• Represent PV Operations on program study teams

Benefits

• Competitive pay and stock options for all employees
• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Education Level: No Education Listed
• Number of Employees: 101-250 employees