Job Title
Manager-2
Business Unit
Global PV
Job Grade
G11A
Location:
Gurgaon
At Sun Pharma, we commit to helping you
Create your own sunshine— by fostering an environment 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 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
- Good communication skills,
- Knowledge on Pharmacovigilance regulatory guidelines and
- Expedited reporting submission requirements
Job Requirements
Educational Qualification –
M.Pharma
Experience –
Tenure : 7 + years
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
