Our client is currently seeking a consultant/contractor to provide supplemental support for a growing Drug Safety Operations function. The primary responsibilities will to provide functional leadership, management support and mentorship for direct reports functioning in the Operations and Systems/Analytics/Reporting roles. Additionally, other activities would include of support ongoing DSPV projects such as drafting of SOPs, other process documentation or storyboards, project/alliance management activities in support of clinical trials and/or global periodic reporting.
This role will provide will provide leadership and managerial responsibility with internal Drug Safety team collaboration for the ongoing process development and management of a growing Drug Safety operations function. The role requires broad understanding of the interdependencies of Drug Safety Operations with the ability to manage and mentor functional reports in Operations, Analytics and Systems to support end-to-end Drug Safety Operations for investigational and marketed products. This role requires broad understanding of best practices within Drug Safety and collaboration within DSPV for departmental development refinement and implementation key activities such as SOPs and other process documentation, systems/tools, metrics/KPIs and Dashboards, analytics and reporting, inspection readiness.
This individual must demonstrate effective direct report management, leadership and collaboration skills with DSPV leadership and cross-functional partners including the ability to ensure appropriate safety reporting capabilities from a Commercial Contact Center. The successful candidate will demonstrate accountability and sense of urgency in leading/managing projects and direct reports in a complex work environment. The 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.
Oversee operations input to routine pharmacovigilance activities performed including, but not limited to: AE case processing, US Contact Center related PV activities, safety systems and analytics with an external host vendor, signal detection, global periodic reporting.
Collaborate within DSPV to further refine policies, guidelines, Standard Operating Procedures (SOPs) and Work Instructions (WINs) to adequately cover a quality PV system.
Maintain good communications with key stakeholders, including Clinical Operations, Clinical Affairs, Medical Affairs, Regulatory Affairs, Global Quality to share and discuss DSPV-related processes.
Participate in or leads relevant cross-functional initiatives or work streams as needed.
As a member of the DSPV team, collaborates with the leaders to drive the organizational strategy, goals, and objectives for the department.
Educate and coach DSPV colleagues in Operation matters, inspire and promote a spirit of team collaboration and growth internally and externally
Bachelor’ s degree in science with 10 years’ relevant experience of which 5 years’ are US-based. Global pharmaceutical drug safety equivalent experience in combination with an advanced degree with less experience may be considered. Health professional degree (PharmD, BSN, RN, MD) is preferred.
Demonstrated knowledge of Drug Safety and pharmacovigilance processes and operations systems with understanding of interdependencies with other functions. Broad knowledge of pharmaceutical compliance practices.
Safety reporting applications: Proficient knowledge of Oracle Argus Safety and related tools. Knowledge of clinical trial operations/electronic data capture and relationship with Drug Safety
Expert knowledge of FDA, GVP, EU safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; knowledge of global safety regulations