Pharmacovigilance Advisor

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 Acorn 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 Tina on 01 2784701 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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