Senior Pharmacovigilance Specialist

Job description

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. KEY DUTIES AND RESPONSIBILITIES 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 applicable Collaborates with GPS Regional PV Teams to ensure the monitoring of local (and applicable regional/area) PV‐relevant hard intelligence, leading the impact assessment of them. Supports the ASR in PV advocacy efforts, in alignment with the AbbVie, GPS, and QPPV Office advocacy guidance. Supports the ASR and GPS Regional PV Team 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. Supports the ASR and GPS Regional PV Team in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections. Supports GPS Regional PV Teams in the development of CAPA in response to observations and the tracking actions to completion in a timely manner. Supports the ASR and GPS Regional PV Team 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. Reviewing periodic safety update reports (PSURs/DSURs) for a determined TA or product to obtain information on the risk/benefit profile of products and share with the local affiliate stakeholders. Partners with GPS Regional PV Team to ensure the preparation of periodic safety reports (e.g., PSUR). Ensures submission of periodic & aggregate safety reports and ensures documentation of evidence Supports the ASR and GPS Regional PV Team 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. Acts as key safety advisor for affiliate cross‐functional partners on safety topics ensuring 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 (SDEAs) 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 GPS Regional PV Team. 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 GPS PV Agreements Database. Compliance with local agreements Supports the ASR and the Regional PV Team 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. Ensures 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. Medical, pharmacy or life-sciences degree (or equivalent). Minimum 2 years at Senior Associate level with a good understanding across the entire PV system Experience working in the pharmaceutical industry in Pharmacovigilance, Clinical Development, Medical Affairs or Regulatory Affairs role. Good understanding of medical concepts and demonstrated st