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The completion of full case information on the database, culminating in Quality Review to ensure accuracy and completeness.
Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist)
Confirmation of Safety Coordinator case registry data
Database searches as necessary
Completion of literature searches as necessary
Completion of remaining case data entry, including narrative or auto-narrative
Completion of risk and quality (label, approval, manual coding & quality review steps)
Clarification of unclear or illegible information from the LSO or Call Centre
Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician
Completion of protocol request forms as necessary
Preparation of deviation memo as necessary
Request deletions as necessary
Single case unblinding
Continuing awareness of company procedures and guidelines to maintain regulatory compliance.
Standard Operating Procedures and Working Practices
Department guidance documents
MedDRA coding dictionary and MedDRA points to consider
Understand relevant safety implications regarding contracts with operating companies and/or marketing partners
Review and make suggestions for system and procedure enhancements
Project Work, Audits, Inspections and other Ad-hoc
Participations in BRM projects, preparations for audits and inspections
Participation in inspection and audits as required (e.g., interviews)
Participation in local or global project teams
Enhancement of the formal training program, through the provision of on going, on-the-job guidance and support.
Provision of on-the-job training and support to other Safety Associates as required
Continuous development of personal skills, whether task or competency related.
Technical training & e-learning
Soft skill development activities
Application and knowledge of Departmental processes and guidelines, regulations and regulatory guidelines, contractual arrangements, product specific information and database/systems functionality to individual case processing and evaluation. Communicate questions clearly and concisely to the appropriate audience and accompany with possible solutions.
Registered Nurse OR
Health/Biomedical Degree OR
Licensed Practical Nurse with Bachelors degree OR
Licensed Practical Nurse without Bachelors degree, but with knowledge of drug safety usually exhibited by minimum 5 years experience in pharmaceutical safety related role.
Pharmaceutical Industry Experience Preferred
Intermediate Information Technology Skills
Data entry experience desired
Accountability for delivery of results
Decision making skills
Problem solving skills
Proactive approach/uses own initiative
Managing own work, ability to prioritize, plan and organize work assignments and work under strict timelines
Ability to follow guidelines, working practices etc. Experience of working with SOP/SWP’s preferred
Quality orientation, attention to detail/accuracy
Good team player
Ability to work independently and to collaborate
Good written and verbal communication skills
Understanding of medical terminology
Ability to summarize medical information
Pharmaceutical industry experience
Experience with a drug safety database
Working knowledge of coding dictionaries
Practical knowledge of global regulatory AE requirements
5 years experience in skills listed above.
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About LanceSoft Inc
Lancesoft is one of fastest growing and largest clinical staffing firm in the U.S. and an employer-of-choice for over 1000+ consultants - this may be your opportunity to join us!
We recruit top-notch talent for Healthcare, Pharmaceutical, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking/ Finance, Manufacturing, Automobile, Media, Transportation, and Government clients coast-to-coast across the US, Canada and India. We are one of the fastest-growing companies in the industry and
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