On behalf of our client, we are currently recruiting for a Pharmacovigilance Advisor to join their Pharmacovigilance Department on a permanent full-time contract.
Flexibility/hybrid working arrangement available combining remote working at home with onsite attendance in their offices in Tipperary.
Key Accountabilities & Responsibilities:
• Adherence to the Quality System and Pharmacovigilance Quality System.
• Case processing and timely reporting of ICSRs and maintenance of the global safety databases.
• Screening of Local and Global Literature for ICSRs and Safety information.
• Conduct and monitor periodic case reconciliations with applicable clients and their business partners.
• Responsible for drafting PVAs and SDEAs and driving them to finalization with all clients and business partners, including on-going maintenance and updates of PVAs / SDEAs when required.
• Assist with GVP inspection readiness activities.
• Assist in the writing and investigation of non-conformances and CAPA management.
• Assist team with Pharmacovigilance compliance activities, KPIs, and metric management.
• Engage in quality system continuous improvement initiatives to enforce the quality culture.
• Support the company during client audits and authority inspections.
• Assist with the preparation of signal detection reports, RMPs, PSURs, and PSMFs.
• Assist in the continuous improvement of SOPs.
• Any other activities as delegated by the EU QPPV / Deputy QPPV.
Attributes & Experience Required:
• B.Sc. in Science, Pharmacy, Pharmacology, Nursing, or related discipline as minimum.
• A minimum of 2 years’ experience working within pharmacovigilance and quality management systems and procedures.
• Commercial awareness & an innate ability to assess the commercial implications of decisions and advice.
• Awareness and understanding of Pharmacovigilance legislation in Europe and the UK.
• Good project management skills with a systematic approach to tasks.
• Ability to keep meticulous records and strong attention to detail, with client satisfaction an integral part of your work ethic.
• Strong interpersonal and communication skills with proven ability to influence people both internally and externally to achieve objectives.
• Motivated self-starter with the ability to work independently.
• Confidence to embrace new challenges within the parameters of qualifications and experience.
• Maintain client confidentiality and observe discretion at all times.
• Strong work ethic.
• Applicants must have the legal right to work in Ireland at the time of application.
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected] Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
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