SHAILESH MARAMPALLI
Bellevue,WA
Summary
Experienced professional with combined expertise across Medical Devices and Pharmaceuticals, specializing as a Senior Medical Writer / Clinical Review Consultant and Drug Safety (PVG) Specialist. Extensive experience authoring, reviewing, and coordinating EU‑MDR–compliant clinical documentation, including CEPs, CERs, SSCPs, and PMCF Evaluation Reports for Class I–III devices. Proven strength in systematic literature reviews (LSPs/LSRs) supporting state‑of‑the‑art, safety, performance, and risk benefit assessments, using global scientific databases and evidence management tools.
Strong background in pharmacovigilance and drug safety, including ICSR processing for investigational and post‑marketed products, AE coding (MedDRA, WHO‑DD), triage, quality review, and regulatory submission readiness. Hands‑on experience supporting PSURs and DSURs, managing safety workflows, mentoring team members, and ensuring compliance with EU‑MDR, FDA, ICH‑GCP, and 21 CFR requirements. Recognized team collaborator with experience across MDR remediation, regulatory submissions, data migration, and backlog clearance initiatives, and a commitment to quality, compliance, and timely delivery.
Overview
11
11
years of professional experience
Work History
Medical Sr. Writer (Sr. Medical Writer Clinical Coordinator and Data Manager)
Zimmer Biomet
10.2019 - Current
- Review/Author Clinical Evaluation documents (Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and Summary of safety and Clinical Performance (SSCPs) for patients and for surgeons) and PMCF Evaluation Reports (PMCFERs) in accordance with global regulatory guidelines (EU-MDR, MDCG, MEDDEV, IMDRF) and internal company procedures, using relevant information compiled from clinical research, peer review publications, risk management files, and post market data as requested for base business activities (device sustenance) and for new product introduction (NPI).
- Participate, strategize, and respond to questions raised by notified bodies on clinical documents, clinical data and for the device under evaluation (DUE) during CE certification, CE renewal and for random audits.
- (As reviewer) Review end-to-end Clinical evaluation documents (CEP, CER, SSCPs, PMCFERs) written by medical writers/contract writers/consultant for ZB product portfolios per regulations and provide feedback.
- (As writer) Conduct cross-functional team meetings, gather inputs and author end-to-end clinical evaluation documents (CEP, CER, SSCPs, PMCFERs) to plan, compile, appraise, analyze (tabulate), evaluate, and conclude data from multiple clinical sources (Clinical studies, registries, literature, and complaints) validate with design V/V, safety & performance (S/P), relevant GSPRs and IFUs for Annual updates, CE renewals, Device scope list enhancements and for NPI projects (CE Certifications)
- Draft LSP & LSR (Literature Search Plan and Report) and perform systematic literature searches in scientific databases on SOTA, S/P (safety and performance) criteria and product bases searches for Clinical Evaluation Reports (CERs) and Periodic Safety Update Reports (PSUR) (Implants/Instruments) for Class I, IIa, IIb & III.
- Develop/update templates (tables) for various clinical data assessments, draft work instructions for certain clinical evaluation documents and provide training on process and methodology of literature searches and data extraction.
- Provide verbal updates and written reports regarding progress of projects on a daily or weekly basis as required. Manage and/or perform additional tasks and projects, as assigned.
Clinical Review Consultant
Global Pharmatek LLC /G-Force (Client: Zimmer Biomet)
06.2017 - 10.2019
- Authored and supported EU‑MDR–compliant Clinical Evaluation Reports (CERs) using evidence from clinical studies, peer‑reviewed literature, risk management files, post‑market surveillance, and registry data for Class I–III medical devices.
- Conducted systematic and targeted literature searches (Embase, PubMed, Google Scholar) to support CER authors, Quality/Design Control, and PMS teams, including state‑of‑the‑art, subject, equivalent, and benchmark device searches.
- Served as primary point of contact for portfolio‑wide literature activities, screening and analyzing thousands of articles and delivering Literature Search Plans/Reports with documented search strategies, inclusion/exclusion criteria, de‑duplication, and bibliographies (EndNote).
- Drafted clinical summaries evaluating device safety and performance, including orthopedic outcomes, survivorship, revision rates, complications, and adverse events, to support CER and PMS documentation.
- Reported literature‑identified complaints and complications to the Complaints team to support Product Experience Reports (PERs).
- Supported Post‑Market Surveillance and Clinical Performance activities by reviewing and verifying clinical data for Clinical Performance Summaries (CPS), Device Performance Reviews (DPRs), and registry analyses (including National Joint Registry).
- Collaborated cross‑functionally with Quality, Development Engineering, PMS, Complaints, and Data Analytics teams; assisted in creation of Market History Records (MHRs) using EtQ.
- Managed and trained a literature search support team, assigning tasks, reviewing deliverables, and ensuring compliant documentation.
- Provided regular project status updates and supported additional initiatives as assigned.
Safety Specialist
Real Staffing / Global Pharmatek LLC (Client: PPD)
11.2015 - 05.2017
- Performed SAE/AE data entry and case processing in validated safety databases (ARGUS 7.0, ARISg/IRT, PRIMO/AERS) for post‑marketing and clinical trial products.
- Supported data migration, triage management, and legacy/backlog case clearances, ensuring timely compliance with regulatory timelines.
- Collected and reviewed AE reports from post‑marketing sources, literature, and ongoing clinical studies; assessed cases for validity, quality, accuracy, and completeness.
- Triaged cases and determined seriousness, expectedness, relatedness, and priority, per client SOPs and regulatory requirements.
- Processed serious and non‑serious ICSRs, including medical coding (MedDRA for AEs, medical history, labs; WHO‑DD/Company‑DD for drugs) and authored medically sound case narratives for medical and quality review.
- Captured and reconciled product complaints (PCs) with AEs and coordinated routing for complaint evaluation.
- Reviewed global (ROW) vendor reports, performed due diligence on discrepancies, and conducted case follow‑ups with reporters and HCPs (e.g., data clarification, co‑suspect, and RMI requests).
- Monitored PVG shared mailbox, assigned cases based on age and priority, and maintained day‑0 compliance.
- Maintained daily workflow tracking, reconciliation of AEs, PCs, and workflow status to ensure accurate and timely case lifecycle management.
- Utilized SAP Business Objects dashboards to extract journal entries and monitor case metrics.
- Coordinated with Medical Safety Physicians to support periodic safety reports (PSUR, PBRER, DSUR), compiling and presenting required safety data.
- Ensured adherence to ICH, FDA regulations, and client SOPs, demonstrating strong task prioritization, deadline management, and effective teamwork in high‑pressure environments.
Drug Safety Specialist
Global PharmaTEK LLC, (In-House and Acorda Therapeutics)
06.2015 - 10.2015
- Performed data entry and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post‑marketing sources in compliance with client SOPs and regulatory requirements.
- Interpreted source documents (medical history, lab results, procedures) and authored clear, accurate case narratives.
- Conducted initial case assessment for seriousness, expectedness, causality, listedness, and reporting requirements using FDA, ICH guidelines, product labeling, and corporate procedures.
- Executed medical and drug coding using MedDRA and WHO‑DD, adhering to project‑specific coding conventions, Package Inserts (PI), Investigator Brochures (IB), and Company Core Data Sheets (CCDS).
- Performed active follow‑up with healthcare professionals, consumers, and partner manufacturers (co‑suspect/OMLs), including issuing clinical safety queries.
- Conducted quality control reviews of ICSRs to ensure accuracy, completeness, and regulatory compliance prior to submission.
- Served as a Safety Liaison coordinating with internal stakeholders and licensing partners to facilitate accurate safety data exchange.
Education
Master of Science - Chemistry
University of Houston Clearlake
Houston, TX, USA05.2015
Bachelor of Pharmacy - undefined
Jawaharlal Nehru Technological University
Hyderabad, TG, IND06.2012
Skills
- Clinical Evaluation (CEP, CER, SSCP, PMCFER)
- EU-MDR 2017/745, MDCG, MEDDEV 271 Rev 4, IMDRF, FDA 510(k)
- Systematic Literature Reviews (strategize, search and compile)
- Embase, PubMed, Google Scholar, DistillerSR
- PMS & PSUR Support
- Participate Support Audits (Internal and Notified bodies - BSi, TUV, HealthCanada, FDA)
Accomplishments
- Closed NB audits; supported CE‑mark approvals for Class III devices
- Owned portfolio‑wide literature searches and SOTA reviews
- Developed risk assessment and literature review procedures
- Trained and mentored medical writers; led process improvements
Timeline
Medical Sr. Writer (Sr. Medical Writer Clinical Coordinator and Data Manager)
Zimmer Biomet
10.2019 - Current
Clinical Review Consultant
Global Pharmatek LLC /G-Force (Client: Zimmer Biomet)
06.2017 - 10.2019
Safety Specialist
Real Staffing / Global Pharmatek LLC (Client: PPD)
11.2015 - 05.2017
Drug Safety Specialist
Global PharmaTEK LLC, (In-House and Acorda Therapeutics)
06.2015 - 10.2015
Bachelor of Pharmacy - undefined
Jawaharlal Nehru Technological University
Master of Science - Chemistry
University of Houston Clearlake