Ashif Ali
Safety & Pv Specialist i @Syneos Health
Signup · Get unlimited contacts
WORK HISTORY
Safety & Pv Specialist i @Syneos Health
Manage the electronic submission of medicinal product data to Eudravigilance, ensuring compliance with the requirements of the European Medicine Agency (EMA) and the XEVMPD regulations.• Retrieved SmPCs and PIL from the regulatory websites of countries, ensuring compliance with local regulations and streamlining access to critical drug information for global stakeholders.• Managed XEVMPD submissions and updates for products across multiple regulatory procedures including MRP, DCP, and National Procedures, ensuring compliance with EMA timelines and data standards.• Maintain and update product information in compliance with EMA guidelines and Article 57 requirements.• Structured Data Submissions: Independently perform timely SDS (e.g. xEVMPD, IDMP) via RIM system.• Manage and update SPOR data elements, including SMS, PMS, OMS and RMS datasets.• Review and maintain MedDRA code values used in EU registrations upon MedDRA version updates by performing gap analysis of changes and update existing values according to RIM system.• Ensure accurate and consistent data entry for medicinal products in alignment with IDMP requirements.• Ensure all regulatory documents and submissions are accurately recorded and tracked within the RIMS.• Collaborated with cross-functional teams to compile and validate product data for XEVMPD submissions under various EU procedures, maintaining data consistency across SPOR and RMS systems.
EDUCATION
Sikkim University
Bachelor of Pharmacy - BPharm, Pharmacy
Mewar University
Master of Science - MS, Clinical Research
ABOUT ASHIF ALI
Regulatory Affairs & RIM professional with 5+ years of experience in EU regulatory…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.