Manager-2

SUN PHARMA; Gurugram District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Sun Pharma in Gurgaon seeks a Manager-2 to lead pharmacovigilance activities, focusing on expedited ADR reporting to global regulators using IISRS and related formats. The role involves PV data configuration, compliance assessment, and cross-functional collaboration to ensure timely safety reporting.

Ideal candidates will have a Master of Pharmacy with 7+ years in pharmacovigilance, strong understanding of regulatory guidelines, and hands-on experience with Argus Safety or similar PV databases.

Qualifications

• Experience in expedited IISRS/ADR reporting to regulatory authorities.
• Knowledge of pharmacovigilance regulatory guidelines.
• Experience with Argus Safety or similar PV databases.

Responsibilities

• Expedited reporting of ADRs to regulators via IISRS, CIOMS, XML.
• Configure products and licenses in the safety database.
• Assess compliance of expedited reports with global regulatory authorities.
• Coordinate reporting rules with the IT team.
• Reconcile products, licenses, and reporting rules in the safety database.

Skills

IISRS reporting

Argus Safety

Communication skills

Pharmacovigilance guidelines

Expedited reporting requirements

Education

M.Pharma

Job description

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 IISRS to regulatory authorities (regulatory compliance role). Working knowledge of Argus Safety will be an added advantage.
• Hands on expertise in processing & reporting of IISRS. 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).