Sruthi Sarvepalli

Mobile: +1-510-***-**** (US)

Email: ad04jj@r.postjobfree.com

Summary:

•Critical thinker with excellent analytical, organizational, and project management skills.

•PhD in Pharmaceutical Sciences.

•Strong experience in signal management and familiarity with EU and US regulatory guidelines.

•Proficient in drafting and reviewing regulatory documents for ANDA, NDA, and IND applications.

•Experience in drafting and updating the labels including IB, GDSs and local locals (USPI, SmPC)

•Skilled in safety monitoring, ICSR review, and safety signal detection from various tools.

•Extensive therapeutic area experience in Oncology, Cardiovascular, Metabolic Disorders, Nervous system, Respiratory system, Pain, Immunology, and Infectious diseases.

•Well-versed in literature review from databases like PubMed, Embase, and others.

•Knowledge in ICH, FDA, and EU guidelines.

•Excellent written and interpersonal communication skills with international conference presentations and peer-reviewed journal publications.

•Recipient of GOLD MEDAL, Meritorious Student Award, Doctoral research fellowship, and appreciation awards from Novartis and GSK.

Work experience:

Doctoral research fellow, St. John’s University, New York, Sep 2019 – Sep 2023

Drafting manuscripts, posters, presentations (slide decks), abstracts, patent and grant documents for the research.

Preparing course materials for undergraduate courses

SERM Scientist: GSK CH Ltd, India, Aug 2017 - Aug 2019:

•Performed continued safety monitoring and evaluation of assigned GSK products, including ICSR review and safety signal detection using Argus, literature, and OASIS ORACLE Empirica signal management.

•Drafted and addressed Response To Queries (RTQ) and supported LOCs in responding to local regulatory requirements.

•Ensured timely completion of safety reports (PBRERs, DSURs, ACOs, RMPs, ASSRs, UERs) to meet global compliance and regulatory requirements.

•Prepared GSK company labels, including core/global data sheets and investigator brochures and monographs.

•Lead innovation, due diligence projects

•Lead RX to OTC switch projects

•Updated the GSK CH labels as a part of Novartis and GSK harmonization.

•Provided clinical safety input to cross-functional teams and drove proactive implementation of risk management initiatives.

•Led and represented the Safety team in cross-functional and safety and labeling committee meetings.

Regulatory Medical Writer: Novartis Healthcare Pvt Ltd, India, Sep 2011 - Aug 2017:

•Ensure the quality and compliance of regulatory documents, including patient narratives, DSURs, and RMPs, for NDA and IND applications.

•Managed protocols, clinical study reports (CSRs), and CTRDs in compliance with ICH GCP guidelines and regulatory requirements.

•Contribute to the label documents including IB, CDS.

•Oversaw outsourced projects as a project manager, from budget discussions to completion.

•Collaborated with global study team members and functions to achieve results and improve document templates and SOPs.

•Drafting scientific manuscripts, abstracts, posters, and slide decks.

Academic qualifications:

•PhD (Pharmaceutical Sciences), St. John’s University, New York, US CGPA: 3.95

•M.S. (Pharm.), National Institute of Pharmaceutical Education and Research, India CGPA: 3.87

•B. Pharm, Kakatiya University, India CGPA: 3.94

Skills:

•Solid understanding of US labeling regulatory requirements.

•Familiarity with pharmaceutical regulatory affairs and global labeling regulatory requirements.

•Strong attention to detail and ability to generate innovative solutions.

•Proficiency in IT systems, including electronic document management systems (EDMS).

•Excellent written and oral communication and organizational skills.

Publications and patents:

•Sarvepalli S, Parvathaneni V, Chauhan G, Shukla SK, Gupta V. Inhaled Indomethacin-Loaded Liposomes as Potential Therapeutics against Non-Small Cell Lung Cancer (NSCLC). Pharm Res. 2022 Nov;39(11):2801-2815.

•Sarvepalli S, Parvathaneni V, Gupta V. Inhalation of repurposed drugs: A promising strategy for treatment of pulmonary arterial hypertension (PAH). Inhalation Magazine 15(1), 20-26.

•Kulkarni NS, Chauhan G, Goyal M, Sarvepalli S, Gupta V. Development of gelatin methacrylate (GelMa) hydrogels for versatile intracavitary applications. Biomaterials Science. 2022 Aug;10(16):4492-4507.

•Gupta V, Parvathaneni V, Sarvepalli S. Formulations for Oral Delivery of Polypeptides, Antibodies, and Proteins; and Uses Thereof. Provisional Patent filed May 13, 2022. Application # US 63/341,727.

Other trainings and activities:

•Diploma in Computer Applications (DCA).

•Program in Pharmaceutical Medicine (PPM) in 2017.

•General Course on Intellectual Property from WIPO in 2010.

•Participated in international conferences and workshops related to drug discovery and pharmacology.

•Active member of AAPS, serving as a leadership team member for the Regulatory Sciences Community and Vice Chair of AAPS Student Chapter.

•Judge for undergraduate seminars.

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