Job Description The Pharmacovigilance (PV) Therapy Area (TA) Specialist works collaboratively with the Head of PV \ Affiliate Safety Representative (ASR), to perform Product Safety Monitoring activities and to ensure that the affiliate complies with local, global, and regulatory requirements and with Good PV Practices. The PV TA Specialist works closely with Pharmacovigilance & Patient Safety Epidemiology and R&D Quality Assurance (PSEQ) regional teams, and affiliate cross functional teams, i.e. Regulatory Affairs, Medical Affairs & Brand Teams, ensuring PV oversight & compliance and supporting the design and execution of medical and commercial strategic initiatives. KEY DUTIES AND RESPONSIBILITIES Collaborate with PSEQ regional teams to support the ASR in ensuring oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations, internal company timelines/standards. Develop a deep knowledge of the Therapy Area - disease knowledge, product knowledge, the safety profile, the benefit risk information, and the competitor landscape. Effectively communicate safety information to stakeholders to positively impact educational strategies and business strategies such as launch excellence; patient experience; emerging safety information. Through local safety monitoring, detect opportunities that add value to the understanding of the use of Abbvie products. Performs surveillance of Local Safety Information and communicates to Affiliate Medical Director (AMD) and PSEQ for escalation and evaluation. Build strong partnerships and work collaboratively with stakeholders and other functions across the business, such as Regulatory Affairs, Medical Affairs, Brand Teams, as applicable Maintain awareness of and input into safety-related product enquiries/issues received from external stakeholders/vendors, working with Medical Affairs, Regulatory Affairs, Affiliate Product Leads (APLs) and the Product Safety Teams (PSTs) as required. Involve internal affiliate stakeholders with respect to the results of product safety monitoring. Support the ASR in setting a solid local safety & PV strategy incorporating proactive PV contributions to ensure a successful product / indication launch at the affiliate. Represent PV as a member of the Affiliate Risk Management Team (ARMT) for an assigned Therapeutic Area and Product, when applicable and coordinates the receipt and distribution of RMP, Core Implementation Plan (CIP) and additional risk minimization measures (aRMM) to ARMT members. Develop a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products. Liaise with ARMT & Benefit Risk Management (BRM) Team and where applicable, seek involvement of relevant PSEQ stakeholders during development or revision of the Australian Specific Annex, Local Implementation Plan (LIP) & local aRMM. Perform the assessment and implementation of the CIP and accompanying aRMM, when applicable Collaborate with PSEQ Regional PV Teams to ensure the monitoring of local (and applicable regional/area) PV-relevant hard intelligence, leading the impact assessment of them. Support the ASR in PV advocacy efforts, in alignment with the AbbVie, PSEQ, and QPPV Office advocacy guidance. Support the ASR and PSEQ Regional teams to ensure quality system mechanisms are in place, including: Development and maintenance of local procedures in line with corporate procedures and local requirements. Impact assessment of new/updated corporate policies, process, and procedures. Local PV Exception Reporting/CAPA process. Business continuity plan and testing. Support the ASR and PSEQ Regional teams in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections. Supports PSEQ Regional teams in the development of CAPA in response to observations and the tracking actions to completion in a timely manner. Support the ASR and PSEQ Regional teams to ensure Adverse Event reporting Periodic Safety Reporting requirements are in place, including: Ensuring 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. Review periodic safety update reports (PSURs) for a determined TA or product to obtain information on the risk/benefit profile of products and share with the ARMT. Partner with PSEQ Regional PV Teams to ensure the preparation of periodic safety reports (e.g., PSUR). Ensure submission of periodic safety reports and ensures documentation of evidence Support the ASR and PSEQ Regional PV Teams in ensuring overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required. Act as key safety advisor for affiliate cross-functional partners on safety topics to address business needs and ensure that 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, and that applicable PV and safety data exchange agreements are implemented. All sources of adverse events and other safety information are identified at the local level and mechanisms are in place for collection and collation of all data by PSEQ. Content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS PV Agreements Database. Compliance with local agreements Support the ASR and PSEQ Regional PV Teams to ensure that a Local affiliate PV Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV. Ensure oversight & management of safety reporting responsibilities in medical affairs activities including Safety Review Plan and ongoing monitoring Review clinical study/medical research protocols and investigator contracts/agreements to ensure compliance with PV Obligations and document appropriately. Report any adverse event within 24 hours as per AbbVie’s policies and procedures Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times Adhere to AbbVie’s internal codes of conduct and compliance processes Other ad hoc duties such as administrative duties, as requested