Affiliate Director, Medical Safety & Surveillance

Job Description
Purpose:
This role is directly accountable for worldwide adverse event case processing including organization, resources, operations and continuous improvement.
This position supports the case processing organization to achieve its mission of improving patient lives globally through industry leading safety and compliance by consistent and accurate delivery of high quality, relevant and timely adverse event information. To create a culture of process improvement, employee development, performance measures, project prioritization and to develop/implement successful solutions by leading the Global Case Management (GCM) function, translating the business vision into broad and actionable strategies. Primarily works in collaboration with various stakeholders to implement, manage and monitor operational activities provided by external providers of pharmacovigilance services for AbbVie.
Responsibilities:
This position is responsible for major operational areas of worldwide adverse event case processing, including organization, resources operations and continuous improvement efforts. Supports Directors/Senior Directors, Global Pharmacovigilance by providing strategic leadership and accountability in GCM and broader PPS department. Helps to define and implement department vision, strategy and priorities.
Core job responsibilities include:
· Plans strategically and oversees overall global system of adverse event receipt, processing and reporting;
complete ownership of end-to-end processes, directing and coordinating roles and responsibilities of internal and external partners, including third-party vendors providing PV services for AbbVie.
· Ensures and monitors system to achieve industry-leading compliance with international regulatory requirements for adverse events reporting and associated activities;
prepares, evaluates, and issues department reports and tracks department metrics/goals, taking independent action on deficiencies.
· Ownership of safety database and related suite of applications for adverse event management, including sponsorship of technology projects, member of cross departmental application portfolio and review/approval of all technology activities for owned systems.
· Directly accountable for performance and oversight of activities provided by third-party Vendors providing PV services for AbbVie, ensuring service-level targets are met or exceeded.
· Supports Global Pharmacovigilance MedDRA group (responsible for medical terminology coding quality in safety database and search strategy, construction/maintenance) and Global Pharmacovigilance Medical Device functionality (coordination of processing and US reporting of stand-alone medical device and combination product incident reports).
· Proactively identifies, evaluates, develops and implements programs and projects which result in tangible improvements to global adverse event processes and systems/databases;
establishes programs toachieve continuous year-on-year advances in case processing productivity and case quality, directly collaborating with third-party vendors providing PV services for AbbVie when required.
· Independently coordinates with other GPV and AbbVie functions conducting periodic reporting, product surveillance, risk management, and legal efforts to provide adverse event data and incorporate their needs into upstream data collection;
effectively integrates adverse event requirements into those functions.
· Anticipates potential and quickly detects actual issues impacting AbbVie’s ability to meet regulatory requirements, deliverable quality or business goals;
rapidly assesses and implements sounds solutions including repair and prevention of future similar occurrences, directly collaborating with external partner providing PV services when required.
· Sponsor projects and leads work streams to address continuous data integrity and regulatory compliance including evaluation/implementation of new regulatory requirements, acquisition/integration/divestiture or product safety information, harmonization with internal partners and business continuity.
· Manages department budget including forecasting future financial and headcount resource needs, contractor/CRO spend, business travel and all other department expenses;
owns functional resource planning, workload balancing and training schedules.
· Supports creation and maintains oversight of case volume forecasting, invoicing, and resource needs in collaboration with third-party Vendors providing PV services for AbbVie.
· Develops and implements resource strategy including outsourcing partners/programs to ensure timely and quality delivery within an inspection-ready environment.
· Provides strategic organizational leadership for accounting department and Global Pharmacovigilance broadly.
· Defines and implements department vision, strategy and priorities in order to balance global regulatory requirements and business needs;
strategically aligns with critical groups and provides functional input to key initiatives in other areas.
· Works closely with third-party vendors to (1) define and implement monitored critical service levels, KPIs, and quality indices, (2) establish consistent processes and practices for effective vendor management, and (3) stimulate innovative process and technology enhancements to continuously improve operational performance and efficiency.
· Serves as an SME in global adverse event case processing to Global Pharmacovigilance and other functional partners within AbbVie;
evaluates issues and opportunities in the larger context of patient safety and regulatory compliance.
· Brings external perspective, insight and benchmarks to bear on problem-solving and business improvement;
has active relevant external network;
accesses and provides thought-leadership in Pharmacovigilance operations across companies.
· Creates and sustains an environment that attracts, develops and retains talented scientific professionals. Plans and conducts active talent management.
· Establishes clear communication channels within the department and across functional teams for both internal and external clients.
· Implements and improves a robust quality system for adverse event case management.
· Establishes and oversees system for adverse event processing conventions, training and knowledge management including tools and procedures;
ensures cross-functional awareness and alignment on relevant case processing and data entry conventions;
provides strategic insight and guidance.
· Proactively identifies, evaluates, develops and implements Pharmacovigilance training external for other AbbVie functions and external partners/suppliers.
· Reviews and evaluates internal and external safety guidelines e.G. ICH and proposes implementation plans and process changes in response to approved regulations.
· Works closely with internal partners to monitor and improve compliance, including R&
D Quality Assurance, Global Pharmacovigilance Quality Systems and EU QPPV;
independently detects and addresses compliance issues with span-of-control.
· Ensures on time and successful conclusion of process deficiency (corrective and preventative actions (CAPAs) and late case investigations;
participates in trending evaluations and enforces repair/prevention;
approves regulatory submissions related to global adverse event management processes.
· Manages internal and external audit preparedness in managing audit process including the development and implementation of responses and associated improvement plans.
· Ensures vendor readiness for, and assists AbbVie and vendor quality units in, vendor audits, investigations, complaints, change control and systems monitoring, and follows-up on implementation of corrective and preventive actions.
· Accountable for preparedness for internal audits and regulatory inspections whose scope includes AbbVie’s global adverse event management;
develops SMEs for direct participation during conduct;
oversees and tracks responses/action plans;
maintains an inspection-ready environment.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required