Pharmacovigilance Therapy Area SpecialistFull-timeAbbVie is dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual.
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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.
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.Through local safety monitoring, detect opportunities that add value to the understanding of the use of AbbVie products.Build strong partnerships and work collaboratively with stakeholders and other functions across the business.Maintain awareness of and input into safety-related product enquiries/issues received from external stakeholders/vendors.Support the ASR in setting a solid local safety & PV strategy.Represent PV as a member of the Affiliate Risk Management Team (ARMT) for an assigned Therapeutic Area and Product.Develop a deep knowledge of the Risk Management Plans (RMPs).Liaise with ARMT & Benefit Risk Management (BRM) Team.Support the ASR in PV advocacy efforts.Support the ASR and PSEQ Regional teams to ensure quality system mechanisms are in place.Support the ASR and PSEQ Regional teams in managing internal PV audits and Regulatory Authority PV Inspections.Support the ASR and PSEQ Regional teams to ensure Adverse Event reporting requirements are in place.Review periodic safety update reports (PSURs) for a determined TA or product.Ensure submission of periodic safety reports and documentation of evidence.Support the ASR and PSEQ Regional PV Teams in ensuring overall training compliance.Act as key safety advisor for affiliate cross-functional partners on safety topics.Ensure all sources of adverse events and other safety information are identified at the local level.Maintain the inventory of local Safety Data Exchange Agreements (SDEAs).Support the ASR and PSEQ Regional PV Teams to ensure a Local affiliate PV Disaster Recovery Plan is established.Review clinical study/medical research protocols to ensure compliance with PV Obligations.Report any adverse event within 24 hours as per AbbVie's policies and procedures.Adhere to AbbVie's internal codes of conduct and compliance processes.Minimum 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.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.Effective communicator and able to work effectively in teams and cross-functional environments.Fluency in written and oral English to facilitate communications.Flexibility and Availability: In line with Australia's 'Right to Disconnect' legislation, we respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT AbbVie is committed to observing high integrity and ethical standards in all its business dealings.
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.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, and embracing diversity and inclusion.
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