Job Description The Regional Pharmacovigilance Associate is accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across assigned region remit.
Reports directly to PV Operational Team Lead, Pharmacovigilance and Patient Safety, Epidemiology, and RDQA (PSEQ).
KEY DUTIES AND RESPONSIBILITIES Develops and maintains local / regional procedures in line with corporate procedures and local requirements.Performs the impact assessment of new / updated corporate policies, process, and procedures.Actively assists with the local PV Exception Reporting / corrective and preventive actions (CAPA) process and assisting with the business continuity plan and testing.Oversee vendor who manages safety data collection, follow-up and case intake of adverse events and other safety information from spontaneous and solicited sources per company process and AbbVie Affiliate RACI Matrix.Performs ICSR expedited reporting according to the local requirements.Conducts local-language medical or scientific literature review.Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and company timelines / standards.Actively assists in managing internal PV audits, audits of affiliate service providers / third parties and Regulatory Authority PV Inspections.Actively assists in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and / or handling of safety information in accordance with AbbVie procedures and local requirements.Ensures content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to AbbVie procedures and local requirements and maintained in the global PV Agreements Inventory.Ensures vendor compliance to contractual agreement.Leads the preparation of periodic safety reports (e.g., PSUR), local annexes, local variations.Ensures submission of periodic safety reports to Regulatory Agency, Ethics Committees and Investigators and ensures documentation of evidence.Ensures 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.Monitors local (and applicable regional / area) PV-relevant hard intelligence, leading the impact assessment of them.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.Qualifications Medical, pharmacy or life-sciences degree (or equivalent).Senior Associate level with a minimum of 2-3 years experience required within the pharmacovigilance field including extensive experience in overseeing PV operational and compliance metrics.Demonstrated understanding of Australian and New Zealand PV and related regulations.Good understanding of healthcare environment and regulatory framework for Australia and New Zealand.Demonstrate a strong compliance mindset, and have a passion for PV Excellence and Patient Safety.Understand business priorities and Integrated Brand Plan strategy. Identifying the connection of how PV can add value.Have a global mindset: cultivate cross-cultural, cross-geographical collaboration.Engagement through internal partnerships and external presence.Effective communicator and able to work effectively in teams and a cross-functional environment.Demonstrated attention to detail and prioritisation.Excellent written and spoken communication and presentation skills.Fluency in written and oral English to facilitate communications with local, regional and global functions and Health Authorities.Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable.
As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours.
We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.
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