Drug Safety Associate I
Location: Morris Plains New Jersey
Description: Kaztronix LLC is at present looking to employ Drug Safety Associate I right now, this vacancy will be placed in New Jersey. Further informations about this vacancy opportunity please give attention to these descriptions. POSITION SUMMARY : Briefly state the objective of this position. Why the job exists (2-3 sentence maximum) This individual will be primarily responsible for recon! ciling reports from the Customer (Call Center) Database involving adverse events (AEs) or product quality complaints (PQCs) indicated to be part of a medical information request (MIR).
This is intended to be a general job description and should not be construed as all inclusive.
ESSENTIAL FUNCTIONS: Define key accountabilities and/or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. % OF TIME Becoming knowledgeable about the types of data and how they are collected.
Evaluating the MS Excel reporting tool being developed to accurately and efficiently identify AEs & PQCs reported as indicated in an MIR. This requires an advanced level of understanding of Excel.
Identifying AEs & PQCs from MIR verbatim language
Reconciling the data for the period Nov 2012 through April 2013.
Management and documentation of non-conformance.
100% Develo! ping the process for reconciling these data.
POSIT! ION SCOPE : Briefly describe what the role is accountable for in terms of size and scope Sales: NA Typical Number of Direct and Indirect Reports: NA Operating Budget: NA # of Functional Areas: 1 Please describe: Safety Services Describe the regional or international scope of responsibility if applicable: NA Describe other scope factors that may apply: Responsible for leading all customer activity with key acute care customers for half of country. NA
Education: Describe the minimum knowledge or educational requirements for the position. Include any degrees or certifications which are required and/or desirable . Required Desirable Subject or Major Associate's Degree BA/BS/BSN x Medical /Pharmacy/Life Sciences/Nursing MA/MS/MBA Doctorate Other: RELATED EXPERIENCE :
Describe the types of experience and typical number of years required for this role:
2-3 years experience in drug safety required
1-2 years pharmaceutical call center e! xperience desired.
Ability to manipulate and evaluate data in MS Excel
COMPETENCY REQUIREMENTS: Describe the competencies required for this position . Click on Box and Enable or Disable Check Mark, as Appropriate:
Integrity / Credo-based Actions x Collaboration and Teaming x Strategic Thinking x
Sense of Urgency x Big Picture Orientation w/Attention to Detail x
Prudent Risk Taking
Org & Talent Development
Self Awareness/Adaptability
x Intellectual Curiosity Results / Perf Driven x
LIST JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED: 1. Working knowledge of pharmacovigilance regulations and methodology.
2. Working knowledge of FDA and ICH guidelines. 3. Knowledge of medical and drug terminology 4. Demonstrates fluency in commercial software (e.g. Microsoft Office Suite).
EXTERNAL AND INTERNAL INTERACTIONS: Describe the frequency and purpose/nature of external in! teractions with customers, other business-related contacts external, an! d other business-related contacts with employees. Internal interactions with Reporting and Analytics, Safety Services, Compliance and Quality Management (C&QM) , Medical Information Center (MIC) COMPARABLES: Provide a listing of other positions that are comparable in size, scope, or are at a similar level to this position. Specialist, Global Drug Safety Unit
Specialist, Call Center PHYSICAL REQUIREMENTS/WORKING CONDITIONS: Describe the extent to which the job must be performed under working conditions that are considered undesirable, potentially hazardous, require travel, or require absence from home overnight
Attachment I
Position Summary Language
Please add the following language at the end of the position summary section if your position supervises/manages other employees.
Responsible for the development of all employees within the department by supporting the development of Human Resources Planning (HRP) programs including ma! nagement development and training to meet current and future business needs. Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
Attachment II
Essential Functions of a Position
The Americans With Disabilities Act (ADA) makes it unlawful to discriminate in employment against a qualified individual with a disability. The law has an impact on the information included in all job descriptions. In order to be in compliance with the ADA, when we update our job descriptions, we must reflect the “essential job functions†of the position, those functions that a disabled or non-disabled person must be able to perform with or with out reasonable accommodation.
As the ADA guidelines suggest, this revision process should include participation by each employee performing the job plus review by supervision.
How Essential Functions are Identified
The! essential functions of a position are the basic job responsibilities/d! uties that an employee must be able to perform, with our without reasonable accommodation.
When determining if a function is essential to the job, several factors should be considered. The key requirement for each function is whether it is a job responsibility that a person in the job must be able to perform in order to accomplish the primary purposes of the position itself. In other words, without the performance of these functions, the job itself would not exist.
It is important to consider these factors when identifying the essential functions for your position:
- Whether the reason the job exists is to perform that particular function
- The availability of other employees capable of performing the function or among whom the performance of the function could be distributed
- Would reassigning or removing the function from the job fundamentally alter the nature of the job itself, i.e.: the effect of someone not being able to! perform the function
- The degree of skill or expertise required to perform the function
We have also included space for you to include “other responsibilities†of your job. These are job duties that are important to the job but not the core responsibilities of the position.
Also, the “machines-equipment†section of the work sheet asks that you list the tools and equipment you must use in order to perform the job.
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Kaztronix LLC.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Thu, 13 Jun 2013 05:03:24 GMT