Job Description We are recruiting a Senior Pharmacovigilance Specialist to join our diverse team in Citywest, Dublin .
The successful candidate will support the Affiliate Safety Representative (ASR) on the coordination and execution of all aspects of pharmacovigilance (PV) at the affiliate to ensure that all of AbbVie's statutory and ethical responsibilities are met.
They will act as the Affiliate's contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety (PPS) function in the absence of the ASR.
They will fulfil National and European Regulatory Authority regulations with respect to Pharmacovigilance conform to AbbVie standards.
Responsibilities: Maintain oversight of areas of responsibility of the affiliate PV compliance status and escalate compliance issues in a timely manner to the ASR to ensure appropriate mitigation Maintain awareness and monitor local post-marketing and clinical PV legislation, to ensure PV legislation changes are communicated to relevant stakeholders for review, impact assessment, implementation, and mitigation according to global procedures.
Comply with local and regional PV regulations and the Affiliate PV System procedure(s) Monitor training compliance of affiliate personnel and partner company staff according to local contract requirements.
Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
Oversight of 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.
For assigned projects, partner with Program Owners to ensure that all 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 are applied in accordance with AbbVie procedures and local requirements.
Maintain and monitor compliance with local agreement Support the ASR with both internal PV audits and Regulatory Agency PV inspections.
Ensure a full and prompt response to regulatory agency requests assigned, for provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
In the absence of the ASR ensure that a Disaster Recovery Plan/Business Continuity Plan is followed in a risk-based manner to allow for continuation of critical business processes for PV.
Qualifications Medical, pharmacy or life-sciences degree (or equivalent).
Minimum of two to five years' experience in the pharmaceutical industry with ideally two years' experience working in in a pharmacovigilance role.
Excellent written and spoken communication and presentation skills.
Excellent written and spoken communication and presentation skills Fluency in written and oral English.
High customer orientation.
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
Sound judgment, strong planning and organizational skills, and the ability to get things done.
Demonstrates strong sense of urgency.
Additional Information 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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