Job Ref: 215607967

Date: 2022-01-19 16:16:52

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PE Global is currently recruiting two Drug Safety Associates (Case Processing) for a 12-month contract role with a leading multinational pharma client based in High Wycombe.

Requirements
• Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness.
• 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.
• 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, review protocol updates for accuract.

• Vendor oversight activities for assigned products.
• Product portfolio subject matter experts.
• Operational management activities for onshore teams and vendors, including but not limited to: workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of ICSRs.

Requirements
• Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD) or Life Science Degree.
• 3-4 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.
• Understanding of medical terminology and ability to summarize medical information.
• Ability to follow guidelines and procedural documents (experience of working with Standard Operating Procedures (SOPs) etc. preferred).

Interested candidates should submit an updated CV
Please click the link below to apply, call Alba on (phone number removed) or alternatively send an up to date CV alba@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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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