Drug Safety Associate

Hobson Prior is currently seeking a Drug Safety Associate for one of the world's largest healthcare companies. This client aims to improve access and affordability to pharmaceuticals enabling healthier communities worldwide. This position will provide responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents.

Job Responsibilities:

• 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 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 staff as appropriate to clarify appropriate information required for case processing.
• Single case unblinding, Serious Adverse Event /Adverse Event reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy.
• Processes & procedures: awareness of and input to company procedures and guidance.
• Completion of all assigned training on company and GMSO procedural documents relating to case processing.
• Completion of training relating to relevant PV Agreements for assigned products.

Key Skills:

• Oriented to quality, attention to detail and accuracy.
• Ability to work both independently and in collaboration with others.
• Proactive approach/uses own initiative appropriately.
• Decision-making and problem-solving skills.

Requirements:

• Licensed Practical Nurse with bachelor's degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years' experience in pharmaceutical safety-related role.
• Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification).
• Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.
• Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas.
• Case processing experience is desired.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.