Responsibilities include but not limited to:
Ensure compliance of global ICSR distribution by correct distribution rule set-up in the Safety Database. This includes:
Regular monitoring of regulatory information system.
Regular review of distribution requirements received from ASRs
Perform plausibility checks and impact analysis of changes in regulations and ensure implementation of distribution rules in Safety Database
Contact person for ASRs for redistribution of cases, updates of distribution rules, contacts, products, timelines and local requirements in the Safety database
Contact person for ICSR reporting requirements for other GPV groups, e.g. Case Processing, QPPV, Compliance, Safety Database Operations
Act as deputy ICSR Distribution Coordinator
Perform regulatory reporting to EMA
Monitor Global Safety database Submission section for received/failed acknowledgements
Maintenance/update of:
Global Safety database contact and distribution rule mapping-functionality
Add/Update Distribution Attribute
RuSH-Card
Global Safety database CPD
Product Port Folio
Distribution-CS-changes document
Handling of ICSR Distribution inbox
Support Safety Database Operations with issue resolution with respect to ICSR distribution
Minimum Education:
Master in Science, Ph.D. in Life Sciences, B.E. or B.Tech or equivalent Excellent
English communication skills
Minimum Experience/Training Required:
Minimum working experience of 10 years in Pharmacovigilance, in particular:
In-depth knowledge of handling of ICSR distribution requirements and global PV regulations.
Knowledge of drug safety database and IT systems maintenance.
Fluent English (both written and spoken).
Experienced professional in the usage of Microsoft Office applications; training according to assigned ISOtrain curriculum Experience with telephone conferences and trainings in English (both as trainee as well as trainer)
Meticulous personality for the review of data and requirements, IT system set-up and confirmations received required.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
Product Development
EPD Established Pharma
India > Mumbai : Mumbai Development Center - EPD
Standard
Not specified
Not Applicable
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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