Senior Specialist Clinical Safety

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Cencora Pharmalex is a leading service provider for the Pharmaceutical Industry globally, specializing in drug and medical device approval, market development, and product maintenance.

We have an exciting opportunity for a Senior Clinical Safety Specialist to join our team in Spain!

Responsibilities :

• Manage Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) : receipt, data entry, narrative writing, follow-up, medical assessment requests, and expedited or aggregate reporting.
• Perform data entry and quality control of adverse event reports in databases such as ABCube Safety-Easy and Argus.
• Code Adverse Events using MedDRA.
• Report reports fulfilling criteria for expedited reporting via validated E2B compliant safety database or through EVWEB, the EMA reporting tool for ICSRs and SUSARs.
• Reconcile SAEs with the clinical study database.
• Support the Clinical Safety Lead in designing and developing Safety Management Plans for clinical trials.
• Assist in writing and submitting Development Safety Update Reports (DSUR) under supervision.
• Review legislation related to Pharmacovigilance Regulatory Intelligence (PV-RI) for clinical trials.
• Assist in preparing internal and external audits / inspections and respond to requests.
• Take on additional tasks and responsibilities in other service lines, project management, and client contact activities as needed and aligned with skills and training.

Skills :

Work Experience :

What Cencora offers

Benefits outside the US may vary by country and are aligned with local practices. Eligibility and effective dates may differ, especially for team members under collective bargaining agreements.

Full-time position.

Affiliated Companies

PharmaLex Spain S.L.U.

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