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Manager - Medical Reviewer - Germany  

Bio Clinica (company)


Posted on : 20 June 2017

Project Description

Tracking Code 1685-050 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. Job Location Frankfurt, , Germany Position Type Full-Time/Regular

Locations

Frankfurt Germany

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