Senior Specialist PV Regulatory Intelligence

Core Job Responsibilities :

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 Tarius

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 :

M.S., M.D. or Ph.D. in Life Sciences, B.E. or BTeach 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.