Drug Safety Associate

Katalyst Healthcares & Life Sciences - Exton, PA

ContractEstimated: $76,000 - $95,000 a year
Job Description:
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

Roles and Responsibilities:
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

Job Skills:
Technical training & e-learning
Workplace shadowing, Mentoring others
Project involvement, 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.
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

Education and Experience:
Registered Nurse OR Health/Biomedical Degree OR Licensed Practical Nurse with Bachelors of degree
Licensed Practical Nurse without Bachelors of degree, but with knowledge of drug safety usually exhibited by minimum 5 years of experience in pharmaceutical safety related role.
Pharmaceutical Industry Experience Preferred
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.