Director, PV Case Management

Role Summary

The Director, PV Case Management will be responsible for the operational management and oversight of case processing activities performed internally and externally by Pharmacovigilance vendors, in both the post-marketing and clinical trials settings. The role ensures compliance with regulatory requirements, corporate and departmental procedures and data handling conventions. This role may be based in Waltham, MA (hybrid) or fully remote; travel to headquarters for meetings may be required at management’s discretion.

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

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