Company: CK Clinical
Location: High Wycombe
Closing Date: 21 Oct 16
Salary (£): 60,000 - 80,000
Mary Tilston is recruiting for a Drug Safety Associate to join a highly established research-based pharmaceutical company. This position is a contract role for the...
Mary Tilston is recruiting for a Drug Safety Associate to join a highly established research-based pharmaceutical company. This position is a contract role for the duration of 3.5 months based in High Wycombe.
The main purpose of your role will be to:
-Be responsible for the completion of full case information on the database, including quality review to ensure accuracy and completeness.
-Triage incoming cases to prioritise for daily workflow management.
-Be responsible for the preparation of SUA summary like analysis of Similar Events.
-Perform the quality review of ICSR which includes review of source documents and ensure that the case is accurate and that corrections to the case, if applicable, are incorporated.
Further responsibilities will include:
-Liaising with case receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
-Other activities relating to case processing as appropriate per case, including but not limited to single case unblinding, serious adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests and reviewing protocol update request forms for accuracy.
-To ensure completion of all assigned training on company and GMSO procedural documents relating to case processing.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in Life Science or equivalent.
-Must have substantial experience in drug safety.
-Must have experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations.
This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37172 in all correspondence.
9 High Street
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