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:

1. Adherence to the Acorn Quality System and Pharmacovigilance Quality System.
2. Case processing and timely reporting of ICSRs and maintenance of the global safety databases.
3. Screening of Local and Global Literature for ICSRs and Safety information.
4. Conduct and monitor periodic case reconciliations with applicable clients and their business partners.
5. Responsible for drafting PVAs and SDEAs and driving them to finalization with all clients and business partners, including ongoing maintenance and updates of PVAs / SDEAs when required.
6. Assist with GVP inspection readiness activities.
7. Assist in the writing and investigation of non-conformances and CAPA management.
8. Assist team with Pharmacovigilance compliance activities, KPIs, and metric management.
9. Engage in quality system continuous improvement initiatives to enforce the quality culture.
10. Support the company during client audits and authority inspections.
11. Assist with the preparation of signal detection reports, RMPs, PSURs, and PSMFs.
12. Assist in the continuous improvement of SOPs.
13. Any other activities as delegated by the EU QPPV / Deputy QPPV.

Attributes & Experience Required:

1. B.Sc. in Science, Pharmacy, Pharmacology, Nursing, or related discipline as minimum.
2. A minimum of 2 years' experience working within pharmacovigilance and quality management systems and procedures.
3. Commercial awareness & an innate ability to assess the commercial implications of decisions and advice.
4. Awareness and understanding of Pharmacovigilance legislation in Europe and the UK.
5. Good project management skills with a systematic approach to tasks.
6. Ability to keep meticulous records and strong attention to detail, with client satisfaction an integral part of your work ethic.
7. Strong interpersonal and communication skills with proven ability to influence people both internally and externally to achieve objectives.
8. Motivated self-starter with the ability to work independently.
9. Confidence to embrace new challenges within the parameters of qualifications and experience.
10. Maintain client confidentiality and observe discretion at all times.
11. Strong work ethic.
12. Applicants must have the legal right to work in Ireland at the time of application.

For a full Job Specification and to apply for this role, please call Tina on 01 2784701 or e-mail tdunne@thornshaw.com. 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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