Drug Safety Associate
Creative Solutions Services, LLC - Horsham, PA

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our client in Horsham, PA is looking for a Drug Safety Associate. If interested, please apply to this ad or send your resume and contact details with the job # and job title in the subject line to recruiter@css-llc.net Responsibility Breakdown: Case Processing: 75% of time Definition: The completion of full case information on the database, culminating in Quality Review to ensure accuracy and completeness. Activities Include:
  • 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
Processes and Procedures: 5% of time Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance. Activities Include:
  • 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
5% of time = Project Work, Audits, Inspections and other Ad-hoc Definition: Participations in BRM projects, preparations for audits and inspections Activities Include:
  • Participation in inspection and audits as required (e.g., interviews)
  • Participation in local or global project teams
Mentoring: 10% of time Definition: Enhancement of the formal training program, through the provision of ongoing, on-the-job guidance and support. Activities Include:
  • Provision of on-the-job training and support to other Safety Associates as required
Personal Development: 10% of time Definition: Continuous development of personal skills, whether task or competency related. Activities Include:
  • Technical training & e-learning
  • Workplace shadowing
  • Mentoring others
  • Project involvement
  • Soft skill development activities
Other information: 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. Education/Related experience:
  • 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
Additional Experience:
  • 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.
Required Skills/Abilities:
  • 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
  • Flexibility/Adaptability
  • Positive attitude
  • 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

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