About this role

Job Title

Manager – PSUR & Aggregate Reports

Location

Gurgaon - R&D

Company

Sun Pharmaceutical Industries Ltd

Job Description

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).
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