Manager - Pharmacovigilance (PSUR)

Sun Pharmaceutical Industries Ltd; Gurugram District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Sun Pharma is seeking a Manager – PSUR & Aggregate Reports in Gurgaon to lead analysis of ICSRs, conduct risk characterization, and prepare PSUR deliverables. The role requires 3–5 years of pharmacovigilance experience with PSUR/aggregate reporting and strong regulatory document knowledge.

MBBS or MD is required. You will work on NCEs or Innovator products, coordinating across PV projects and ensuring adherence to safety management plans.

Qualifications

• 3–5 years of experience in Pharmacovigilance with PSUR and aggregate reports.
• Proficient in causality assessment and MedDRA coding.
• Experience with regulatory documents (DSUR, PSUR/PBRER, PADER, RMP, SMP).

Responsibilities

• Analyze individual case safety reports (ICSRs) within aggregate contexts, evaluating seriousness, expectedness and causality and integrate findings into cumulative safety profiles.
• Perform Risk Characterization.
• Review published scientific literature for PSUR.
• Prepare Summary tabulation for PSUR.
• Prepare special situation cases write ups for PSUR; interpret trends and signals across datasets to assess benefit-risk balance.
• Work on PV projects such as collating responses to assessment reports from agencies.
• Evaluate Safety Notifications to qualify ESIs/SSIs.
• Review Clinical Trial Protocols for PV perspective.
• Review Safety Management Plans.

Skills

Causality assessment

MedDRA coding

PSUR/PBRER knowledge

Regulatory document requirements

Data interpretation

Education

MBBS or MD

Job description

Job Title:

Manager – PSUR & Aggregate Reports

Business Unit:

GPV

Job Grade

G10

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 Role:

• Analyze individual case safety reports (ICSRs) within aggregate contexts, evaluating seriousness, expectedness, causality and integrate findings into cumulative safety profiles for New Chemical Entities (NCEs) or Innovator Products.
• Risk Characterization
• Review of published scientific literature for PSUR
• Preparation of Summary tabulation for PSUR
• Preparation of special situation cases write up for PSUR Interpret trends and emerging signals across datasets to assess and update the product’s benefit-risk balance
• Work in Pharmacovigilance projects as assigned such as collation of response to assessment reports received from the agency
• Perform Evaluation of Safety Notifications to qualify Emerging Safety Issues (ESIs) / Significant Safety Issues (SSIs)
• Review Clinical Trial Protocols for NCEs or Innovator Products from PV point of view
• Review Safety Management Plans.

Educational Qualification

• MBBS or MD

Experience

• Tenure: 3 to 5 years Proficient in causality assessment, MedDRA coding, and understanding regulatory document requirements, including DSUR, PSUR/PBRER, PADER, RMP, SMP, Clinical Study Protocols of New Chemical Entities (NCEs) or Innovator Products.

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).