Specialists in Pharma, Clinical & IT Recruitment

Drug Safety Officer

Reference:
DSO-PG
Job Type(s):
PVG / Drug Safety
Salary:
Salary negotiable
Town/City:
Prague
Contract Type:
Contract
Date Posted:
09/10/2013 17:23:00
Start Date:
09/10/2013
End Date:
18/12/2013

Description

My client a Global CRO has opened a new vacancy within Drug Safety Team. They are looking to recruit a Drug Safety Officer to their team on a permanent basis in Prague.

 

 

Key Responsibilities:

 

·         Safety Officer is responsible for guarding patients’ safety in clinical trials and conducting adverse event reviews and handling according to regulatory requirements (EC and Other Regulatory Bodies) and sponsor’s ethical responsibility.

 

·          Conducting adverse events review and handling (including complaints reporting, SAE criteria, UADE assessment, coding, etc) and according to regulatory requirements, Safety Process and SOPs, and European regulatory requirements.

·         
Interaction with CEC for the purposes of safety data collection, data reconciliation, and providing source documents for the CEC reviews.

·         
Preparing adverse event reports for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements (e.g., expedited UADEs, aggregate reports and other regulatory documents as requested). 

·         
Provide additional information and updates to the complaint handling group regarding patients’ outcomes and associated/related complaints. 

·         
Advise research coordinators and CRAs to properly report adverse events and provide the proper supporting documentation for SAEs (serious adverse events).

·         
Supporting CRAs and sites in AE reporting training, and cross function training and expertise regarding complaints handling

 

Skills/Experience Required:

 

·          A bachelor’s degree in a related biological or life science discipline, or a nursing diploma/associates level degree is required.

·         
Requires 3-7 years of experience in clinical research, with at least 2 years Safety/AE handling within the medical device industry.

·         
Requires knowledge of global regulations and guidelines for AE/UADE reporting, conducting Clinical Research and ICH/GCP practices.

·         
Requires understanding of medical device regulatory requirements and documents, device accountability and clinical safety medical device regulatory documents/adverse events reporting and handling.

·         
Knowledge of interventional coronary or peripheral products such as stents, open or minimally invasive cardiac surgery or other class II devices.

·         
Experience with remote data capture strongly preferred.

·         
Ability to communicate and relate well with key opinion leaders and clinical personnel 

·         
Excellent written and verbal communication skills, presentation skills, interpersonal skills and analytical skills are a must. Proficiency in English language is a must.
 

 

More information available on request.

 

For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070

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