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Drug Safety Physician

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About the role

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Drug Safety Physician
 
Chennai, India.
 
ICON Clinical Research is a respected global CRO providing drug development solutions to the Pharmaceutical; Biotechnology; and Medical Device industries.  We are a growing organisation, acquiring a number of businesses which augment and compliment the services which we offer.
 
We are currently looking to strengthen our established Drug Safety team based in Chennai in the recruitment of a Drug Safety Physician.  This is a new role and is due to further business wins.
 
As a Drug Safety Physician you will 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
  • 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)
  • 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
  • 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-authorisation studies, spontaneous reporting and literature  
  • 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
  • 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
 
Role Requirements  
  • Medical Degree from an accredited institution of Medical education
  • The successful candidate will ideally have 1 or more years of clinical research or industry experience. 
  • You will have excellent verbal and written communication (English and local language) combined with excellent computer skills; Excel and Access skills preferred and basic presentation skills 
What’s Next
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment
 
*LI-VS1
 
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