Hobson Prior are recruiting for as a Drug Safety Specialist II to join a research-based biopharmaceutical company in either Uxbridge, Cambridge or to be home-based. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them.

Job Responsibilities:

• Sets work priorities and direction with input from Manager.
• You will review, extract and accurately enter AE data from ICSR reports from both investigational and post marketing products.
• Review, enter, and verify follow-up information for cases and make accurate determination of significant information.
• Understand case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
• Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative.
• Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries.
• Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports.
• Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.
• Will interact with other PVE functional areas to process adverse events efficiently and reliably.
• Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (i.e., obtaining clarification or follow-up information).
• Recognises issues/concerns in a timely and appropriate manner.
• Meet specific data and quality targets for case handling.

Key Skills:

• Excellent interpersonal and communication skills, both written and oral.
• Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
• Demonstrates initiative, teamwork and accountability.
• Demonstrated success working both independently and in collaboration with others.
• A quality driven individual with strong attention to detail and accuracy is required.

Requirements:

• Healthcare professional degree (i.e., RN, PharmD) and little to no pharmacovigilance experience or industry experience.
• A minimum of 2+years of pharmacovigilance experience and a BS degree in a life sciences field.
• A minimum of 3+ years of experience in the pharmacovigilance field and an AA degree preferred.
• Safety database and data entry experience is preferred.
• Understanding of medical terminology and the ability to summarize medical information is preferred.
• The ability to assess data and understand the medical/safety implications.
• Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred.
• Understands safety database structures and is familiar with data retrieval tools.

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.