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Title : JA- Drug Safety Associate II -711
State : Pennsylvania   Date : Oct 11, 2018
Experience Level :  
Position Type : Drug Safety Associate II      

This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Horsham, PA

Job Title: Drug Safety Associate II

Duration:  9+ months (extendable) contract on W2


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 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 Project Work, Audits, Inspections and other Ad-hoc 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 Enhancement of the formal training program, through the provision of on going, on-the-job guidance and support. Activities Include: Provision of on-the-job training and support to other Safety Associates as required 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.


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 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 RELATED 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.


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. 


Many Thanks,   

Sree Kanth
Associate Recruitment Manager
NewAge Clinical,
A Division of NewAgeSys, Inc.
231 Clarksville Road, Suite 200,
Princeton Junction, NJ 08550
Tel#: 609-945-1736, Fax: 609-228-4079

Inc 5000 Company for 8th Time 

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