At Sun Pharma, we commit to helping you Create your own sunshine— by fostering an workplace where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine
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 team-oriented 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
Valuable communication skills,
Knowledge on Pharmacovigilance regulatory guidelines and
Expedited reporting submission requirements
📌 Manager Pharmacovigilance Gurugram
🏢 SUN PHARMA
📍 Gurugram
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