Drug Safety Specialist

I am exclusively partnered with an international Contract Research Organisation looking for an exceptional Drug Safety Specialist to join their growing team. This is an exciting period of growth for the business as they bring their Pharmacovigilance in house. If you’re a driven Drug Safety professional please read below….

Roles and Responsibilities:

• Oversight of day to day safety monitoring activities and safety operations for all investigational products
• Responsible for the day to day functions such as safety case management (AEs / SAEs / SUSARs) including data triage and case validation assessment, data processing in the safety database
• Fulfilling expedited safety case (SAEs / SUSARs) reporting requirements for ICH & EMA & FDA and local health authorities.
• Maintaining Safety Data exchange agreements (SDEAs) and SLA with co-license partners, distributers and local safety units
• Initiating requests for follow up safety case-relevant information
• Preparation of safety aggregate reports such as DSUR, RMP, PRBER, PAERs, CSR and the clinical part of dossier for regulatory submission and documentation management
• Responding to queries from Health Authorities, authorised Representatives and safety partners
• Performing timely safety data reconciliation
• Fulfilling good documentation practice by appropriate managing project-relevant documentation.

Requirements:

• Life Science degree (pharmaceutical sciences, biomedical sciences)
• Experience in pharmacovigilance and drug safety
• Good working knowledge of Pharmacovigilance regulations and relevant health authorities’ regulations
• Experience using Aris G, Argus, Eudravigilance
• Good Knowledge of medical terminology: MedDRA, Who Drug dictionary
• Fluent in English Language and other languages is a plus

If you are interested, get in touch with me ASAP…

Dan Hockaday

Pharmacovigilance & Drug Safety Recruitment Consultant

Email: Dhockaday (at) barringtonjames.com

Phone: 00441293776644