Pharmacovigilance Advisor

Pharmacovigilance Advisor

Are you ready to make a difference in the pharmaceutical industry? One of our clients is hiring a Pharmacovigilance Advisor to join their dynamic Pharmacovigilance Department on a permanent basis. If you are passionate about drug safety and thrive in a collaborative environment, we want to hear from you!

Position: Pharmacovigilance Advisor
Location: Hybrid working arrangement available, combining remote work from home in the Republic of Ireland with onsite attendance at our main office in Clonmel, Co. Tipperary.
Contract Type: Permanent, Full Time

What We're Looking For:

To succeed in this role, you should have:

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.

Key Responsibilities:

As a Pharmacovigilance Advisor, you will:

Ensure adherence to our Quality Systems and Pharmacovigilance protocols.
Process cases and report Individual Case Safety Reports (ICSRs) while maintaining global safety databases.
Screen local and global literature for safety information and ICSRs.
Conduct periodic case reconciliations with clients and business partners.
draught and finalise Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).
Support GVP inspection readiness and assist in writing non-conformance reports and CAPA management.
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.
Collaborate on the continuous improvement of Standard Operating Procedures (SOPs).

If you are excited about this opportunity and meet the qualifications, we invite you to apply!

Please note: Applicants must have the legal right to work in Ireland at the time of application