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Job Details

Senior Drug Safety Associate - Nottingham

Company: Worldwide Clinical Trials
Reference: VN1000
Closing Date: 26 Mar 18
Type: Full Time
Salary (£): Negotiable

Job Summary:

Worldwide Clinical Trials are looking for a permanent Senior Drug Safety Associate, based from our Nottingham office (can consider home-based following successful completion of probationary period)


To assist with the collection, processing and evaluation of the information on Serious Adverse Events (SAEs) that are reported to the Company, including preparation of summary narratives of the information contained in the case, assigning the proper regulatory reporting status, and accurately entering the data into Drug Safety Database.

Assist the Drug Safety Manager/Officer in the preparation of periodic safety reports to be submitted to regulatory authorities worldwide and provide routine database searching, extraction and reporting services to the department.


Tasks may include but are not limited to:

* Interact with project team members and investigative site personnel in order to obtain valid and full information regarding SAE cases.
*  Supervise the activities of the Drug Safety Associates
* Prepare SAE narratives and forward SAE for QC.
* Interact with assigned contact personnel in Sponsor’s Safety and Medical Affairs departments regarding safety related issues and to provide accurate SAE information for reporting purposes (including regulatory reporting).
* Warrants the generation of Safety Update Reports (ASR, Periodic Line listings) and other regulatory reports.
* Conducts project-specific safety training for the Project Team
* Ensuring all safety data originated in projects assigned are handled in accordance with WCT global standard operative procedures and local working practices.
* Act as a support person in the preparation of study-specific Safety Monitoring Plans
* Contribute in the safety signal generation and evaluation process and in the preparation of documents for other ad hoc reports.
* Be always updated on the laws/guidelines/regulations of drug safety in the region.

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.


* Medical /science background (nursing preferred) with relevant clinical experience
* A minimum of 4 years of exemplary departmental service in Drug Safety or comparable ex-WCT drug safety experience
* Ability and willingness to travel 10% or as needed
* Average computer skills (Microsoft Office applications)
* Knowledge of medical terminology
* Excellent communication skills
* Detail oriented
* Fluent in written and verbal English
*At least 2 years previous PV experience


* Bachelor degree in a science-related field, or nursing, or equivalent.

Apply for this job: Senior Drug Safety Associate - Nottingham

Contact Information:

Address:  Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
Tel:  0207 121 61 61
Website:  Visit Our Web Site

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