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