Job Ref: 213353060

Date: 2021-03-12 16:03:02

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PE Global is currently recruiting for a Drug Safety Associate (case processing) for a leading multi-national Pharmaceutical client in High Wycombe.

The role:
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.

Responsibilities:
• 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 Analysis of Similar Events
• Perform quality review of Individual Case Safety Reports (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 Global Case Receipt and/or Global Medical Safety Operations Physicians (GMSOP) staff as appropriate to clarify appropriate information required for case processing

Requirements:
• Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
• Licensed Practical Nurse with Bachelor’s degree, or with knowledge of pharmacovigilance usually exhibited by 2-4 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

Interested candidates should submit an updated CV.
Please click the link below to apply, call Amparo on (phone number removed) or alternatively send an up to date CV amparo@peglobal.net

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert

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