Sindhuri Ammineni
Serm Senior Scientist @GSK
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WORK HISTORY
Serm Senior Scientist @GSK
Bengaluru, IN
Signal Detection & Evaluation• Perform routine signal detection using cases, literature, and safety databases with the safety physician.• Discuss, prioritize, document, and escalate safety signals with safety leads.• Retrieve and analyze data from relevant sources and present conclusions clearly.• Prepare concise signal evaluation and exploratory safety documents.• Monitor and communicate safety issues related to product or manufacturing defects.Aggregate Reports & Regulatory Submissions• Author PBRERs and other periodic safety reports within timelines.• Support license renewals with addendum reports, line listings, and overviews.• Provide safety input for global regulatory submissions and agency queries.Risk Management• Author and update global/regional Risk Management Plans.• Contribute to benefit–risk assessments.Labelling• Maintain Global Product Information and support label updates.• Recommend and respond to safety-related labelling changes and queries.
EDUCATION
CMR College of pharmacy
Master of Pharmacy, Pharmacology
SKILLS
ABOUT SINDHURI AMMINENI
Creative pharmaceutical professional with more than 10 years of experience in pharmacovigilance, specializing in aggregate report writing (PSUR/PBRER, PADER, PR), signal management, ICSR case processing, and regulatory reporting. Adept at leveraging scientific expertise and analytical skills to ensure compliance, enhance patient safety, and support regulatory submissions. Seeking a challenging role that allows me to contribute my skills and experience toward organizational growth while fostering continuous professional development.
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