Safety Officer, EU-Centralized Products For Ahmedabad

Hi,

We have an opening for Safety Information Officer, Centralized Products for Ahmedabad Location.

Purpose of Job:

To provide regulatory support to ensure clinical safety particulars of Accord Marketing Authorisations within EMENA remain compliant with current legislation and Authority requests

Specific Job Responsibilities:

• Coordinate and improve the process of Renewals & Maintenance Activities for EU-Centralized Products (CPs).
• Coordinate and improve the process of safety variations (SV) for EU-CP products.
• Coordinate the Reference Product Comparison activity for EMENA region
• Raise CRFs for all upcoming safety changes related to EU-CP products, and coordinate LR for NAPs
• Collaborate with PV, Quality, Regulatory Strategy, IP and Medical team on safety labelling updates
• Reviews dossiers prepared by the Intas RA team for regulatory compliance before submission
• Vice-Chair of Safety Information Committee organize, prepare the agenda and propose new topics
• Ensure the Safety Information Compliance for EU-CP are robust deviations, audits, HHA etc are up to date
• Oversee the monthly metrics
• Ensure LR have the local QMS aligned with SOPs
• Oversee EU-CP regulatory agreements
• Ensures compliance with regional guidelines for CP products
• Collaborates with AW team for implementation of SVs for EU-CPs
• Meet all compliance timelines when performing regulatory activities
• Maintain regulatory documentation, spreadsheets and databases
• Maintain regional regulatory standard operating procedures (SOPs)
• Carry out regulatory training activities within and outside the Department
• Monitor regulatory inboxes
• Perform general regulatory duties as required
• Support non-Centralized Products activities as described above