Senior Pharmacovigilance Specialist

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

The Senior Pharmacovigilance Specialist works closely with the Area Safety Representative (ASR) and Global Patient Safety (GPS), and Regional PV Team to ensure compliance with local regulations, corporate standards, and risk management obligations in an assigned Therapeutic Area. You will monitor and communicate local safety information, lead cross-functional safety education initiatives, and manage risk minimisation activities including the assessment and implementation of Risk Management Plans, safety agreements, and periodic safety reporting requirements. With a strong ability to build partnerships across Medical Affairs, Regulatory Affairs, and Brand Teams, this role plays a critical part in embedding a proactive safety culture and ensuring the highest standards of patient safety at the affiliate level.

Collaborates with the Regional PV Team 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 including disease and product knowledge, safety profile, benefit risk information, and competitor landscape. Effectively communicate safety information to stakeholders to positively impact educational strategies and business strategies such as launch excellence, patient experience and 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 Global Patient Safety (GPS) for escalation and evaluation. Reviews summary reports of local research-related activities and communicates any safety insights/findings with Medical Teams and GPS. Leads product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources Build strong partnerships and work collaboratively with stakeholders and other functions across the business, such as Regulatory Affairs, Medical Affairs, Brand Teams, as applicable Maintains 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.. Supports the ASR in setting a solid local safety & PV strategy incorporating proactive PV contributions to ensure a successful product / indication launch at the affiliate and in the local risk management activities for an assigned Therapeutic Area and Product in alignment with local regulations with the Affiliate Medical Director (AMD). Develops a deep knowledge of the RMPs (Risk Management Plans) of products and coordinates the receipt and distribution of RMPs, Core Implementation Strategy (CIS) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders. Liaises with the affiliate stakeholders and Office of Risk Management and where applicable, seek involvement of relevant global stakeholders during development or revision of the Australian Specific Annex, Local Implementation Strategy (LIS) & local aRMM. Performs the assessment and implementation of the CIS and accompanying aRMM, when