MUKKU LAKSHMI SRAVANTHI
Medical Affairs and Medical Communication
Chennai
Summary
Experienced medical professional with strong background in clinical review and analysis. Known for collaborative teamwork and achieving impactful results in dynamic environments. Skilled in presentations, conducting meetings, medical documentation, regulatory compliance, and quality assurance. Adaptable, reliable, and ready to contribute to advancing healthcare standards.
Overview
5
5
years of professional experience
10
10
years of post-secondary education
5
5
Languages
Work History
Senior Medical Reviewer
Fortrea Scientific Private Limited
05.2023 - Current
- Provide medical review of safety documents such as aggregate safety reports and signal detection, clinical and regulatory documents such as Clinical Study Reports (CSRs), Investigation Brochure's (IBs), protocols, clinical and nonclinical overviews and summaries, benefit-risk assessment documents and risk management plans F value documents.
- Medical review of manuscripts, product monographs and training materials.
- Preparation of presentation slides for the Advisory board meetings, interacting with the Key opinion leaders.
- Attend and conduct ABMs both locally and abroad and preparation of reports and executive summary slides.
- Conduct the KEE management and align with the experts on conducting and executing the ABMs
- Provide training in disease states and protocol specific requirements across the region, participate in training opportunities to advance knowledge of drug development and good clinical practice guidelines.
- Identify the process and implementation issues/gaps needing attention and provide input into necessary remediation.
- Support internal and external training assignments and workshops, support project managers for resourcing, solution development and process improvement.
- Reviewed clinical trial protocols and study reports to ensure compliance with regulatory standards and internal guidelines.
- Conducted thorough evaluations of medical data and documentation, identifying discrepancies and providing recommendations for resolution.
- Mentored junior reviewers by providing training on best practices in medical review processes and regulatory requirements.
- Engaged in regular communication with sponsors to address queries related to study findings, fostering strong professional relationships.
- Served as a subject matter expert during audits, demonstrating a strong understanding of regulatory requirements and company policies related to medical reviewing.
- Coordinated effectively with global teams, managing multiple projects concurrently while meeting deadlines consistently without compromising quality standards.
- Developed training materials for new hires, allowing them to quickly assimilate into their roles as Medical Reviewers while minimizing errors associated with learning curves.
Associate Medical Reviewer
IQVIA
03.2022 - 05.2023
- Provided comprehensive medical review expertise and ensured efficient, quality data management products to customer needs.
- Provided project management support in the areas of structured patient data review per clinician's perspective.
- Medical inputs to clinical and regulatory documents such as protocols, CRFs, ICFs.
- Identified patient anomalies to ensure medical congruency/plausibility of a subject data per protocol.
- With minimal guidance, provided project management expertise working with clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provided technical expertise.
- Maintained strong customer relationships, tracked service performance and provided leadership to identify root causes of issues and implement remedial action.
- Ensured timely follow-up and resolution of compliance issues, served as Subject Matter Expert (SME).
- Demonstrated ability to work on multiple projects and manage competing priorities and continuously looked for opportunities to improve efficiency of tasks and quality of deliverables.
- Provided therapeutic area/indication training for the project clinical team and attended Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
- Showcased strong customer focus skills and established and maintained effective working relationships with coworkers, managers and clients, managed Internal and external trainings.
Principal Investigator
Amaris Clinical- A Division of Caplin Point Laboratories
01.2021 - 01.2022
- Faced FDA Audit virtual and on-site with Zero 483 Executing clinical study as per ICH-GCP and Declaration of Helsinki.
- Ensure the safety and well-being of the study subject.
- Protocol development and study conduct and designing different studies for different formulations according to the regulatory requirements.
- Managing different kinds of Screening, Recruiting the subjects, dosing the Investigational Product, Accountability, Adverse Events, Causality Assessment.
- Preparation and review of Adverse event reporting forms, and submitting them to the ethics committee and regulatory.
- Ensure the study is conducted in compliance with the SOPs and GCP and GLP regulatory guidelines.
Education
Doctor of Medicine - Pharmacology
NRI Medical College
Guntur, Andhra Pradesh 05.2016 - 06.2019
Bachelor of Medicine and Bachelor of Surgery - MBBS
Southeast University
05.2006 - 06.2013
Skills
- Word
- Excel
- Power point
- Trend reports
- Power BI
- Medical writing
- Teamwork
- Problem-solving
- Excellent communication
Websites
Therapeutic Experience
- Neuroscience, Neurology - Peripheral neuropathy, Diabetic neuropathy, Insomnia, Vertigo, Epilepsy, Multiple Sclerosis, Alzheimer's (Phase I and IV), Psychiatry - Schizophrenia, Bipolar Depression (Phase I and II), Rare Disorders - Spino Muscular Dystrophy(SMA) (Phase II and III)
- Oncology, Solid Tumors - Breast (HER2+, Triple Negative Breast Cancer), Gynecological Tumors - Cervical Cancer, Epithelial Ovarian Cancer
Timeline
Senior Medical Reviewer
Fortrea Scientific Private Limited
05.2023 - Current
Associate Medical Reviewer
IQVIA
03.2022 - 05.2023
Principal Investigator
Amaris Clinical- A Division of Caplin Point Laboratories
01.2021 - 01.2022
Doctor of Medicine - Pharmacology
NRI Medical College
05.2016 - 06.2019
Bachelor of Medicine and Bachelor of Surgery - MBBS
Southeast University
05.2006 - 06.2013
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