Senior Specialist PV Regulatory Intelligence job opportunity at Abbott.

Home Jobs In India Tag: Job Senior Specialist PV Regulatory Intelligence position at Abbott


DatePosted 17 Days Ago bot
Abbott Senior Specialist PV Regulatory Intelligence
Experience: 10-years
Pattern: full-time
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degreeMBA
loacation India - Mumbai, India
loacation India - Mumbai....India

      JOB DESCRIPTION: 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.       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Product Development       DIVISION: EPD Established Pharma          LOCATION: India > Mumbai : BKC Building       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)                  

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