Company/Organization: Qtech-Solutions Professional Development Center

Description:

(Prior training will be provided for preparation in accordance to below Tasks and responsibilities)
The internship will consist of “real world” documentation and case study scenarios that represent on the job applications.

Major Tasks and Responsibilities: (Learnings)

• Review medical records to cases in accordance with US FDA Regulations
• Extract relevant Medical Data from the Medical Information provided and entered data into company case template
• Prioritize cases based on seriousness of adverse events in accordance with SOP and regulatory guidelines.
• Perform triage on incoming cases by assessing seriousness, expectedness, casualty and regulatory clock start date for FDA submissions
• Evaluate and document event terms, case classifications (validity & seriousness)
• Perform data entry into the safety database (word format) for initial or follow up cases from pre and post-marketed drugs.
• Apply knowledge on MedDRA coding for issuing queries for all discrepancies found while coding on situational case scenarios on following concepts
• Create comprehensive and accurate narratives for both serious and non-serious cases procured from relevant, related information from various source documents.
• Reconcile serious adverse events reported during the conduct of a clinical research trial in the clinical database with serious adverse events (SAEs) recorded in the Safety Database.
• Perform reconciliation to assure that serious events are accurately captured, and interpreted.

Qualifications:

• Healthcare professionals (e.g. RN, PA, MD, PT.RPh, PharmD, Medical Technologist)
OR
• Preferred degree in: Pharmacology/Toxicology, Pharmacy, Industrial Pharmacy, Pharmaceutical Chemistry, Public Health/Medicine, Medicine, Nursing,
OR
• Bachelor degree or higher in life science or Biological sciences

Other Qualifications:
• 0-6 months of experience in the pharmaceutical/healthcare industry (clinical trials)
• Strong verbal and written communication skills
• Willingness to get trained
Candidates with more than 2 years of experience will not be considered for training/internship program, but will qualify for training and placement assistance program only. Upon completing training internship program our candidates might be considered for placement assistance and contract position.

Other Conditions
• Upon the training internship program each Intern will also receive job preparation support, which includes: resume writing, interview tips as guidelines, narrative preparation, mock interviews with experienced Drug Safety Professionals
• Job placement assistance will be offered for qualified candidates after internship program while the success rate will depend on the candidates performance during the internship program
• NO INTERNSHIP RELOCATION is required

Length/Availability:

60 days

Start Date:

10/25/14

End Date:

, 12/25/14

Additional Info:

This field is always in demand and look for candidates with
• Clinical Research / Data Management.
• Pharmacology or Toxicology degree.
• Pharmacy (or) Pharmaceutics (or) Industrial Chemistry degree.
• Public Health degree.
• Biotechnology / Bioinformatics degree.
• Medicine / Nursing degree
• Statistics, Bio-statistics degree
• Computer Science and Engineering

JOB ORIENTED TRAINING & PLACEMENT PROGRAMS
Training Highlights
• 24/7 Access to the Training Material
• In class Trainings (Optional)
• Job Oriented Training
• Hands-on Experience
• Technical Support
• Resume Preparation
• Mock Interviews
• Placement Support

POST TRAINING JOB SUPPORT

Qtech offers Placement assistance support to candidates meeting the eligibility criteria upon successful completion of training. Email us your most recent resume to get enrolled into placement support program and qualify by securing minimum score points needed to qualify. We assist candidates in resume preparation, narrative writing and conduct mock interviews for increased success rate of each candidate.

We will get you prepared for jobs open in market and for possible interviews. Please keep in mind the success rate solely depends on candidate’s performance, job market, experience, technical expertise, and writing and communication skills.

Tags:

Drug  Safety  Associate  Pharmacovigilance 

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