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Manager - Medical Reviewer Frankfurt Germany,  

Bio Clinica (company)


Posted on : 20 June 2017

Project Description

Job Description 
Supervision and coordination of following activities:  
  • Member of medical review India project team. 
  • Single point of contact between client and medical review project team India for the smooth functioning of the project. 
  • Communicate between the Bioclinica management, Client and the Bioclinica project team. 
  • Record, maintain and track the medical review metrics of the project and share with project team as necessary 
  • Obtain feedback from the client related to medical review of ICSRs and work with India project team to improve the medical review quality. 
  • Collaborate with Engagement manager, CRM sponsor and project sponsor and collect the concerns related to medical review of ICSRs and share them effectively with the client 
  • Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports 
  • Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion 
  • Perform triage of cases and determine seriousness and relatedness across products as assigned 
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative. 
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas 
  • Conduct assessment of litigation cases across products as assigned 
  • Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups 
  • Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate 
  • Acquire and maintain knowledge of applicable Global Health Authority regulations 
  • Perform any other drug safety related activities as assigned 
  • Provide feedback to the data entry, quality review, triage and corresponding team leaders on the case quality and improvement areas. 
  • Provide guidance for Data entry and quality reviewers. Take lecture sessions on the product pharmacology, trends, disease areas to the India project team. 
  • Follow-up on reconciliation discrepancies. 
  • Follow departmental AE workflow procedures. 
  • Train and mentor new team members as per requirements of the project. 
  • Recruit, select and train team members 
  • Act as guide, coach and counselor for the medical review team  
   

Required Skills   
  • Subject Matter Expertise in medical review 
  • Proven experience in customer handling and relationship. 
  • Proven ability to perform task management. 
  • Must have good presentation skills and the ability to give presentations. 
  • Experience in entire drug development life cycle. 
  • Relevant product and industry knowledge 
  • Experience with relevant safety databases and software applications 
  • Requires a proactive approach and excellent written/oral communication and interpersonal skills. 
  • Strong interpersonal skills required to interact with clients, management, and peers effectively. 
  • Effective cross-department communication. 
  • Ability to document and communicate problem/resolution and information/action plans. 
  • Person should be familiar with MS Office tools/Data base and other applicable software. 
  • Ability to educate/ train the team members as needed. 
  • Contributing to the ongoing enhancement of Pharmacovigilance process and SOP s including internal and external training. 
  • Maintaining Pharmacovigilance systems including global safety database.   
 

Locations

Frankfurt Germany

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