PRIMARY FUNCTION/OBJECTIVE

　　Fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance (PV) to ensure

　　that all of AbbVie’s statutory and ethical responsibilities are met.

　　CORE JOB RESPONSIBILITIES

　　Leadership and management

　　• Build and maintain effective business relationships across the affiliate to support the implementation

　　of patient safety standards.

　　• Seek continuous improvement to optimize the affiliate PV system and contribute to regional and global

　　process improvement initiatives, working with Global Pharmacovigilance and Patient Safety (PPS) subject matter experts.

　　PV operation

　　Responsible for below tasks:

　　• In charge of monthly PV dashboard and PV metrics data entry timeline in timely manner, ensure data quality and accuracy is met. If any compliance issue detected, must report to PV Manager.

　　• If required, accountable for clinical trial related tasks including but not limited: AE, SAE, SUSAR, reporting and reporting requirement, Blind SUSAR communication, trial tracking log maintenance, assigned as PV point of contact to Clinical operation-Site Monitoring and Management (SMM) team.

　　• Monitoring new product launches and product expansion in launch readiness tasks.

　　• Performing quarterly Organized Data Collection (ODC) program monitoring.

　　Quality Management System

　　• Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.

　　• Oversee training compliance of partner company staff according to local contract requirements.

　　Adverse Event & Periodic Safety Reporting

　　• Ensure that processes, procedures and systems are in place for intake, processing, conducting follow up,

　　translating and reconciling adverse events and other safety information reportable to PPS from

　　spontaneous and solicited sources and from clinical studies.

　　• Ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic

　　and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with

　　corporate PV procedures and with local and regional PV regulations as required.

　　Partnership with business partner with possibility for identification and/or handling of safety

　　information

　　• Partner with Program Owners and commercial leaders to ensure that all business partnerships involving

　　activities where there is a reasonable possibility for the identification and/or handling of safety

　　information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements.

　　Safety Data Exchange Agreements (SDEA) and other PV Agreements

　　• Ensure the content of local SDEAs and other PV agreements conforms to AbbVie procedures and

　　local requirements and maintains the inventory in the PPS PV Agreements Database.

　　• Maintain and monitor compliance with local agreements.

　　Audits and Inspections

　　• Ensure that any audit/inspection responses/corrective actions are completed according to the schedule.

　　• Support local QA and R&D PV QA to conduct vendor audits and complete vendor corrective action plans.

　　Risk Management

　　• Review Risk Management Plans (RMPs) and implement risk minimization measures at the affiliate according to AbbVie procedures and local requirements.

　　• Understand the RMPs and information on the benefit/risk profile of products applicable for the Affiliate.

　　• Ensure the appropriate development and revision of Local RMPs and/or Country Specific Annexes, if

　　applicable, liaising with Affiliate Risk Management Team (ARMT) & Benefit Risk Management (BRM) Team during development and revision of local documents.

　　• Partner with ARMT & BRM Team during development or revision of the Local Implementation Plan (LIP) & local additional risk minimization measures.

　　Safety Monitoring

　　• Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency.

　　• Understand and monitor incoming local safety data and communicate changes or potential concerns to the PPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.

　　• Ensure a full and prompt response to regulatory agency requests for provision.

　　After Hours Availability & Business Continuity

　　• Ensure that an after-hours process is in place for the reporting of AEs.

　　• Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to

　　allow for continuation of critical business processes for PV.

　　INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS

　　• Affiliate medical, regulatory affairs, clinical, quality assurance and customer service personnel.

　　• Affiliate Marketing, Sales and Operations personnel to ensure that all employees are trained and

　　understand their responsibilities for reporting of any safety information.

　　• National Regulatory Agency responsible for product safety.

　　• Pharmacovigilance and Patient Safety, including but not limited to International PV operational excellence (IPEx), Area PV Product Lead, Benefit-Risk Management and QPPV Office.

　　• Healthcare Practitioners, consumers and patients.

　　PREFERRED QUALIFICATIONS

　　• Medical, pharmacy or life-sciences degree (or equivalent). Master’s degree is preferred.

　　• At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is

　　required.

　　• Excellent written and spoken communication and presentation skills.

　　• Fluency in written and oral English is essential to facilitate communications with Pharmacovigilance

　　and Patient Safety, Area/Regional Medical and other headquarters functions.

　　• Fluency in written and oral local language a requirement to facilitate communications within the

　　affiliate medical department, and with the National Regulatory Agency.

　　• High customer orientation

　　• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality

　　and integrity.

　　• Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.

　　Critical Success Factors

　　• Builds and maintains strong relationships with affiliate colleagues (e.g. Medical Affairs, Regulatory Affairs, Commercial) and PPS and tailors communication to different stakeholders to enhance understanding of PV requirements and elevate the PV internal brand.

　　• Learns fast, grasps the “essence”, ability to manage complexity and changes to change course quickly

　　where indicated to add value to the PV system.

　　• Acts consistently with AbbVie’s ethics, obligations and local laws – putting patient safety, partnerships

　　and overall AbbVie’s interests before individual, immediate team and functional interests.

　　• Focused on compliance; identifies, manages and escalates issues in a timely manner.

　　• Strengthens the use of product safety knowledge and channels scientific safety evidence and benefit-risk

　　information to area and affiliate stakeholders to positively impact business strategies.

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.