Senior pharmaceutical safety specialist

Job Overview

As a Pharmacovigilance Advisor, you will play a vital role in ensuring the safety of patients by monitoring and reporting adverse events associated with pharmaceutical products.

* Process and report individual case safety reports (ICSRs) in a timely manner, maintaining global safety databases.
* Screen local and global literature for ICSR and safety information.
* Conduct and monitor periodic case reconciliations with clients and business partners.
* Draft and finalize pharmacovigilance assessment (PVA) and signal detection evaluation and analysis (SDEA) reports, including ongoing maintenance and updates.
* Assist with good vigilance practice (GVP) inspection readiness activities.
* Investigate non-conformances and manage corrective action preventions (CAPA).
* Support pharmacovigilance compliance activities, key performance indicators (KPIs), and metric management.
* Engage in quality system continuous improvement initiatives.
* Support client audits and authority inspections.
* Prepare signal detection reports, risk management plans (RMPs), periodic safety update reports (PSURs), and periodic safety summary reports (PSMRs).

* Bachelor's degree in science, pharmacy, pharmacology, nursing, or a related field.
* Minimum two years' experience in pharmacovigilance and quality management systems.
* Commercial awareness and ability to assess commercial implications.
* Awareness of pharmacovigilance legislation in Europe and the UK.
* Strong project management skills and attention to detail.
* Excellent interpersonal and communication skills.
* Motivated self-starter with ability to work independently.
* Confidence to embrace new challenges within qualifications and experience.
* Maintain client confidentiality and observe discretion at all times.

This is an excellent opportunity to join a dynamic team and contribute to the safe use of pharmaceutical products. If you are passionate about pharmacovigilance and have the required skills and qualifications, we encourage you to apply.

As a member of our team, you will have access to ongoing training and development opportunities. We are committed to creating a positive and inclusive work environment that supports the well-being of our employees.