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Title : BA- Medical Information Specialist -434
State : New Jersey   Date : Oct 8, 2018
Experience Level :  
Position Type : Medical Information Specialist      
Description
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: Ridgefield, NJ


Job Title: Medical Information Specialist


Duration: 12+ months (extendable) contract on W2


Duties:


Perform active phone follow up on selected medically important cases on behalf of US Pharmacovigilance (PV), in order to optimize PV data collection and analysis. 
Identification of those adverse event reports which warrant active phone follow up. Liaise with RM physicians regarding additional medically important cases which are deemed as requiring phone follow up. Provide RM physicians with any newly obtained information which is deemed important to communicate quickly. Accurate documentation of follow up attempts, both successful and unsuccessful. Accurate and timely submission of new follow up information to Global Case Management for processing. Ongoing update of TSS Communication Module to track all follow up attempts until activity is considered closed. Compliance with all training requirements, global BI policies and procedures, and local and global regulations. Additional Pharmacovigilance Operations tasks, such as, Clinical Trial (CT) reconciliation, query management and closure, case narrative quality review, CT protocol review Regulatory and/or Organizational Requirements: This role requires a thorough understanding of all local and global regulations, and internal policies and procedures, regarding the collection and reporting of adverse events and other safety-relevant information. Job Complexity: Operating in a complex local and global organization with evolving regulatory and business needs, the role requires excellent written and verbal skills and the ability to engage with external customers (i.e. HCPs) to represent Pharmacovigilance in a professional and compliant manner. The role requires the ability to adjust to rapidly changing priorities and to recognize the need to escalate issues appropriately, as needed. Interfaces: Global PV Risk Management physicians Global Case Management teams US PV Operations team Job Expertise: Deep understanding of medical concepts; broad knowledge of the pharmaceutical life cycle, with focus on pharmacovigilance in particular; understanding of safety reporting regulations both in US and internationally, and the respective need for compliance. Job Impact: As a member of the US PV organization, the scope of this position has direct influence on the compliance activities within the US OPU. Failure to process and report adverse event information according to company policies and global regulations could put the company at risk of non-compliance. Non-compliance with federal regulations could result in citations and fines for the Company.


Skills:


Strong fund of medical knowledge; able to converse with medical experts in multiple specialty areas regarding clinical information. Knowledge of regulatory requirements in the area of GCP, ICH guidelines, 21 CFR FDA regulations as they relate to Pharmacovigilance (preferred). Strong organizational and prioritization skills. Ability to communicate clearly and effectively in writing and verbally; excellent documentation practices. Demonstrates excellent interpersonal skills. Excellent judgment and decision making qualities




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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
Email: sree@newageclinical.com

Website: http://www.newageclinical.com, www.newagesys.com
Inc 5000 Company for 8th Time 

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