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.
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