The Director will lead a team of DSPV Specialists and Operation managers and will play a visible and pivotal role in growing this function within Alkermes Drug Safety and Phamacovigilance (DSPV). This individual will be accountable for the processes and performance of all case processing activities, including procedures and tools for managing effective and compliant submissions for all investigational and marketed products. This individual will also be responsible for ensuring that all the study related start up, management and close out activities are consistent, cost-efficient and in compliance with regulatory requirements.
This individual must demonstrate effective direct report management, leadership and collaboration skills with DSPV leadership and cross-functional partners. The successful candidate will demonstrate accountability and sense of urgency in leading/managing projects and direct reports in a complex work environment. Candidate will provide vision, leadership, strategic planning and coordination of drug safety operations. Candidate must have strong written and verbal communication skills and demonstrate a willingness to roll-up their sleeves and assist with work projects as needed.
- Complete oversight of all case management and study management activities
- Activities include, ICSR processing and submission in accordance with applicable regulatory requirements
- Study management activities including SAE reviews
- Vendor management (clinical and post-marketing)
- Clinical trialsupport
- AE and SAE Reconciliation
- Study document review
- Safety management plans
- Coding reviews
- Remain informed for all appropriate current health authority regulations and guidance globally
- Ensure compliance with all regulatory reporting requirements and timelines for reporting safety data from clinical studies and post-marketed products
- Responsible for PV vendor set-up, negotiating, managing and executing PV vendor agreements (e.g., MSA/SOW)
- Assist operations managers with day-today activities , monitor and evaluate the performance and quality of PV external and internal staff responsible for case management and study management activities
- Completes ongoing standardization of PV activities for both post-marketing and clinical trial case processing and study management.
- Participate in the implementation and maintenance of the global safety databaseprocesses to ensure compliance with global AE reporting requirements
- Ensure implementation of processes and systems internally (where necessary) and externally (PV vendor) to ensure AE information is received timely, reviewed for completeness and consistency, and case follow-up activities are completed to facilitate signal detection and aggregate safety reporting activities
- Ensure literature search strategies for AE reporting are performed on weekly basis and all relevant articles are assessed for adverse reactions and benefit-risk information.
- Ensure reconciliation of AE reports received from other company operating units, affiliates, contractual vendors, partners, CROs, as applicable
- Ensure SAE reconciliation of clinical and safety databases for ongoing clinical studies
- Work with internal/external partners to develop standardized procedures for AE handling and training (e.g., Investigator Meeting or Site Initiation Visit trainings)
- Ensure consistency across programs for organized data collection activities such as Patient Support Programs and Investigator Initiated Trials
- Ensure PV regulations are monitored for updates and that changes are implemented as appropriate
- Efficiently utilize tools and metrics to supervise staff output, timelines, and quality of work product including budget-related activities. Advises Operations Managers on adjustments needed to staffing levels and operational processes to ensure operational effectiveness.
- Oversee team member productivity to ensure goals are met. Develop corrective action plans for productivity and process improvement as needed.
- Participate in departmental development activities including SOP and Work Instructions development, Audits and Inspection readiness in close collaboration with PV Quality and Compliance
- Ensure consistency is built in to the development of Safety Data Exchange Agreements (SDEAs), PV agreements, Statements of Work, manage partner relationships, and ensure compliance with PV agreements
- Manages budget to include annual and long range forecasting
- Provides coaching and performance management for direct and extended reports
- Promotes team collaboration and growth internally and externally
- Mentor, train, or supervise new and junior personnel on best practices and therapeutic area knowledge
- Other tasks as assigned
- Minimum of 8 years’ relevant industry experience, or a combination of relevant education and experience.
- A minimum of three years Case Processing experience
- A minimum of 3 years of personnel and vendor management experience.
- Demonstrated ability to work effectively either independently or collaboratively in a cross-matrixed team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
- Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively.
- Demonstrated ability to manage a team of direct reports including mentoring and developing direct reports.
- Familiarity with Pharmacovigilance and drug development, including knowledge of applicable international clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
- Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and Argus Safety systems
- Bachelor’s degree in science or healthcare related field