Pharmacovigilance Advisor New

2 weeks ago

Dublin, Dublin City, Ireland CPL Full time
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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