Drug Safety Associate IPosted: November 7, 2009
We are currently sourcing for a position with our Direct Client and would like to discuss this opportunity with you.
Established in 1995, Rangam Consultants is a multiple service provider in the Information Technology, Scientific, Engineering and administrative fields. We have a proven track record for successfully delivering mission critical consulting, support and recruiting services to various government and Fortune 500 clients.
The details for this position are as follows:
Job Title: Drug Safety Associate I
Job Code: RCI-WJNJ-4195/4196
Job location: 185TABORROAD,MORRISPLAINS,NJ
Duration: 6 Months
Start Date:ASAP
JOB DESCRIPTION:
Description:
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 Requirements: 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 on going, 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
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
RELATED EXPERIENCE:
• Pharmaceutical industry experience
• Experience with a drug safety database
• Working knowledge of coding dictionaries
• Practical knowledge of global regulatory AE requirements
3 years experience in skills listed above.
If interested:
Please provide us the following information:
1) Hourly rate on W2 or expected salary _________
2) Resume in Word format __________
3) Contact information, where we can reach you _________
4) Three professional references with their Name, Company Name, Title and Phone # ________
5) Your Status (Citizen/EAD/Green Card)______
I look forward to hearing from you.
Best regards,
Seema Singh
Rangam Consultants Inc.
Somerset NJ 08873
Direct No:- 908 450 9299 Ext - 311
Alt Phone No: 908 704 8843
Fax: 908 253 6550
Email: Staffing@rangam.com
Alt e-mail id: rangamconsultantsinc@gmail.com
WWW.RANGAM.COM
FOR ALL CURRENT OPEN JOBS @ RANGAM CLICK HERE
Message Id : #ID# Please refer to job code RCI-WJNJ-4195 when responding to this ad.
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