Sr.Drug Safety Physician

Sr.Drug Safety Physician
ICON Clinical Research - Bangalore, Karnataka

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a DSP 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 principals 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. For more info visit at mentioned link