Manager-2

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Roles & Responsibilities

The candidate will be involved in expedited reporting of ADR cases to various regulatory authorities worldwide and compliance assessment. In addition, will be involved in the products and licenses configuration and reconciliation in the safety database.

Area Of Responsibility

Expedited reporting of ADR cases to regulatory authorities from the safety database – submission through E2b gateways or CIOMS or XML files.

Products and licenses configuration in safety database.

Assessment of compliance for the expedited reports submitted to various regulatory authorities worldwide.

Assessment of expedited reporting requirements and ensure configuration of reporting rules through the IT team.

Perform reconciliation of products and licenses in the safety database.

Perform reconciliation of reporting rules in the safety database.

Competencies Required:

Technical Competencies:

Hands on expertise in reporting of expedited ICSRs to regulatory authorities (regulatory compliance role). Working knowledge of Argus Safety will be an added advantage.

Hands on expertise in processing & reporting of ICSRs. Working knowledge of Argus Safety will be an added advantage.

Behavioral Competencies: