|Location: High Wycombe, Buckinghamshire||Salary: £23 - £24 per hour|
|Type: Contract||Contact: Sam Davies|
Drug Safety Associate
Drug Safety Associate needed for a multinational pharmaceutical organisation based in High Wycombe who are looking to employ an experienced Drug Safety Associate strong knowledge of safety reporting and regulatory compliance.
The successful Drug Safety Associate will want to work for this client not just because it's a great opportunity but also because they will receive a payrate of up to £24 per hour.
What the role entails: Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.
Some of the main duties of the Drug Safety Associate will include:
* Triage of incoming cases to prioritize for daily workflow management
* Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
* Preparation of SUA summary: Analysis of Similar Events
* Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
* Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
What you need to be the successful Drug Safety Associate:
* Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
* Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
* Licensed Practical Nurse with Bachelor's degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years' experience in pharmaceutical safety-related role
* Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
* Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!