Shruti Moondra
Medical Writer at PAREXEL International (India) Private Ltd- Claim this Profile
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English Full professional proficiency
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Hindi Native or bilingual proficiency
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Spanish Elementary proficiency
Topline Score
Bio
Credentials
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Introduction to Breast Cancer
CourseraSep, 2019- Nov, 2024 -
Health Research Fundamentals
NPTELOct, 2017- Nov, 2024
Experience
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PAREXEL International (India) Private Ltd
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700 & Above Employee
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Medical Writer
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May 2018 - Present
Pharmacovigilance activities such as Signal detection (monthly and quarterly), Literature review (Triage), Trending analysis (quarterly), Summarization of literature review for aggregate reports, review and update of Auto-labelling list following MedDRA version update , SDP update. Expertise to actively manage and evaluate risks associated with assigned projects and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks while working as a product scientist.• Trained in preparation of and/or assistance in the preparation of Periodic Benefit Risk Evaluation Report (PBRERs) and six-monthly SUSAR reports (SSRs) for pharmaceutical products in accordance with client SOPs and requirements/conventions, as required.
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Swami Vivekanand Group of Institutions
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Higher Education
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100 - 200 Employee
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Asst Professor
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Dec 2010 - May 2018
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Education
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University of Santo Tomas
Doctor of Philosophy - PhD, Pharmacy -
Shri G S Institute of Technology & Science
M.pharma, Medicinal and Pharmaceutical Chemistry -
Swami Vivekananda Institute Of Science And Technology
B.Pharma, Pharmacy -
Queens college
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University of Santo Tomas
Doctor of Philosophy - PhD, Pharmacy