Pharmacovigilance Advisor New

3 weeks ago

Nenagh, County Tipperary, 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 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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