
Adverse Event Specialist
2 weeks ago
Pharmacovigilance professionals are in high demand, and this role offers a unique opportunity to join a team dedicated to ensuring the safe use of medications.
This is a permanent full-time position within our Pharmacovigilance Department, where you will work closely with clients and business partners to maintain global safety databases and ensure adherence to quality systems.
You will be responsible for:
•Processing and timely reporting of adverse event reports (ICSRs) and maintaining global safety databases.
•Screening local and global literature for adverse events and safety information.
•Conducting and monitoring periodic case reconciliations with clients and their business partners.
•Drafting and finalizing pharmacovigilance assessments (PVAs) and signal detection evaluation reports (SDEAs).
•Assisting with GVP inspection readiness activities and quality system continuous improvement initiatives.
•Engaging in quality culture enforcement and supporting client audits and authority inspections.
•Preparing signal detection reports, risk management plans (RMPs), periodic safety update reports (PSURs), and periodic safety update report summaries (PSMFs).
Requirements- A bachelor's degree in science, pharmacy, pharmacology, nursing, or a related field.
- A minimum of 2 years' experience working within pharmacovigilance and quality management systems and procedures.
- Commercial awareness and the ability to assess commercial implications of decisions and advice.
- Awareness and understanding of pharmacovigilance legislation in Europe and the UK.
- Strong project management skills with a systematic approach to tasks.
- Ability to keep meticulous records and strong attention to detail.
- Excellent interpersonal and communication skills with proven ability to influence people both internally and externally.
- 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.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. You will be working in a dynamic and supportive team environment, with a focus on delivering high-quality results.
This is an excellent opportunity to join a leading Irish provider of specialist scientific recruitment and contribute to the success of our company. If you have the required skills and experience, we encourage you to apply.
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