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 recent 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

📌 Safety Officer, Eu Centralized Products For Ahmedabad
🏢 Adecco India
📍 Ahmedabad