Drug Safety Physician job in

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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

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At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential.
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