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Drug Safety Physician

India-Trivandrum
Permanent
Reference: 045876
This vacancy has now expired.
Description
Provide medical and safety support to the activities of ICON Project Teams in order to ensure that projects are conducted according to the highest ethical principles and medical standards, in accordance with GCP and good pharmacovigilance practices and in compliance with applicable legal and regulatory standards.
 
Overview of the Role:
  • Medical review of assigned cases to include: review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of  Adverse Drug Reactions (serious and non-serious)
  • Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile
  • Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON
  • Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorization studies, spontaneous reporting and literature
  • Review and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project
  • Review and provide input to the Project Specific Procedures and participate in project related meetings
  • Communicate with the client to an extent as described in the Project Specific Procedures
  • Provide assistance in the preparation and conduct of code-break activities
  • Potentially, provide support to the Drug Information & Pharmacovigilance  Product Support (call) Centre and the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions
  • Travel (approximately 5%) domestic and/or international
  • Other responsibilities as assigned.
 
Role Requirements / Skills / Experience Required:
  • Medical Degree from an accredited institution of Medical Education (MD or DO)
  • A minimum of 1 or more years of clinical research or industry experience
  • Safety Database experience preferred
  • Excellent computer skills; MS Excel and MS Access skills preferred
    Due to the nature of this position it may be required for the employee to travel.  Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license.
 
Benefits
Working for ICON you will be provided with an excellent benefits package.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.
 
What’s Next
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
 
ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 

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