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Manager - Medical Reviewer Frankfurt Germany,
Bio Clinica (company)
Posted on : 20 June 2017
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
- 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.
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