Pharmacovigilance Therapy Area Specialist

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.Through local safety monitoring, detect opportunities that add value to the understanding of the use of Abbvie products.Perform surveillance of Local Safety Information and communicate 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.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.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
All AbbVie employees are responsible for maintaining the Company's reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.
Soliciting and / or accepting / attempting / offering bribes or any illegal gratification is therefore cause for immediate dismissal.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
AbbVie is an equal opportunity employer and 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.
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