Job Title: Pharmacovigilance Advisor
Location: Hybrid working arrangement available, combining remote work from home in the Republic of Ireland with onsite attendance at our main office.
Contract Type: Permanent, Full Time
Job Description
We are seeking a skilled and detail-oriented Pharmacovigilance Advisor to join our dynamic Pharmacovigilance Department on a permanent basis. As a key member of our team, you will play a vital role in ensuring the safety and quality of our products.
As a Pharmacovigilance Advisor, your primary responsibility will be to process cases and report Individual Case Safety Reports (ICSRs) while maintaining global safety databases. You will also be responsible for screening local and global literature for safety information and ICSRs, conducting periodic case reconciliations with clients and business partners, drafting and finalizing Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs), and supporting GVP inspection readiness and assisting in writing non-conformance reports and CAPA management.
In addition, you will engage in continuous improvement initiatives to enhance our quality culture, assist during client audits and authority inspections, contribute to the preparation of signal detection reports, Risk Management Plans (RMPs), and other key documents, and collaborate on the continuous improvement of Standard Operating Procedures (SOPs).
We are looking for an individual who is passionate about drug safety and thrives in a collaborative environment. If you are excited about this opportunity and meet the qualifications, we invite you to apply.
Required Skills and Qualifications
* A B.Sc. in Science, Pharmacy, Pharmacology, Nursing, or a related discipline.
* A minimum of 2 years of experience in pharmacovigilance and quality management systems.
* Strong commercial awareness and the ability to assess the implications of your decisions.
* A solid understanding of Pharmacovigilance legislation in Europe and the UK.
* Excellent project management skills with a methodical approach to tasks.
* A meticulous record-keeping ability and a keen eye for detail.
* Strong interpersonal and communication skills to influence and collaborate effectively.
* A self-motivated attitude with the ability to work independently.
* The confidence to embrace new challenges within your qualifications and experience.
* A commitment to maintaining client confidentiality and discretion at all times.
* A strong work ethic and a passion for excellence.
Benefits
This is a permanent, full-time position offering a competitive salary and benefits package. The successful candidate will have the opportunity to work in a dynamic and collaborative environment, where they can grow and develop their skills and expertise.
As a member of our team, you will have access to ongoing training and development opportunities, as well as a comprehensive benefits package that includes health insurance, pension scheme, and generous holiday entitlement.
Others
Applicants must have the legal right to work in Ireland at the time of application.