Safety Regulatory Intelligence Associate

1 week ago


Remote, India IQVIA Full time

Job Overview
- Maintain a repository of, and communicate on, international, regional and national legislations, recommendations and guidelines related to vigilances for all ranges of products such as medicinal products, medical devices, cosmetics, nutraceuticals.
- Appropriately identify and address potential regulatory issue that may have an impact on the current Pharmacovigilance procedures and strategies.
- Review and the analysis of the international, regional and national regulations and guidelines in vigilances for all ranges of products
- Ensure strong interface with Regional PV representatives to analyze, interpret and validate changes in national safety regulatory requirements to translate them into Global Pharmacovigilance processes.
- Communicate international, regional, and national Safety Regulatory requirements to Global Pharmacovigilance and when needed collaborate with concerned PV team to ensure accurate implementation and compliance
- Support the ICSR Reporting Rules Configuration in PV database when needed.
- Maintenance and evolutions of the Safety Regulatory Intelligence tools and systems
- Deliver on an ad-hoc or regular basis, regulatory updates for internal purposes



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