Senior Manager/Associate Director, PV Operational Excellence
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager/Associate Director, PV Operational Excellence.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Senior Manager/Associate Director, PV Operational Excellence, working on the GPSE team, you will be empowered to serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.
Oversee operations performed by the PV BPO vendor including contract compliance, quality and timeliness of deliverables.
Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and/or vendors performing case management, case intake, literature review; call centers
Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, legal case processing, vendor oversight, etc.
- Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according to company timelines and quality standards
- Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicable
- In partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRs
- In partnership with the Global Standards and Compliance team,
- Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level
- Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners
- Lead PV relationship with PV BPO vendor and/or vendors performing case management to ensure compliance with SLAs
- Support LOCs in PV tasks responding to queries and requests regarding case handling
- Interface with commercial quality for product complaints; assist in obtaining follow-up when necessary for adverse events, product quality complaints or other safely information
- Direct relationship with and output ofBPO partner(s) in accordance withSLA
- Liaises with financial / project management for budget planning
- Approve actual invoices and confirm accuracy of spend and bills
- Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:
- Adherence to KPIs and SLAs
- Forecast demand
- Issue escalations
- Continuous improvement initiatives
- Change management
- Establish and manage vendor oversight procedures
- Partner with QA to establish and manage BPO vendor quality agreement procedures include vendors performing case management/intake activities or literature review and surveillance
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Experience in people management and well developed skills in teambuilding, motivating and developing people.
- Minimum 6 years pharmaceutical or health care related industry experience required.
- Minimum 5 years PV experience with 3 years experience working with CROs, vendors, and relationship management required
- Global experience with CROs, vendors and relationship management preferred
- Demonstrated skills in negotiation and consensus decision making
- Critical thinking and analytical skills and ability to make key decisions
- Demonstrated effectiveness in external partner relationship management
- Understanding of medical/scientific terminology
- Good knowledge of PV regulations for the global pre-and post-market, i.e. FDA, EMA, ICH GVP
- Experience with safety databases, including MedDRA and WHO Drug