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I’m Dr. Abhijath Murali Pharm.D (BCMAS, RAPS-certified, PMP) - A Top Rated Plus Freelancer with 90k+ earnings from Upwork with cross-functional experience at IQVIA, Cipla, IPCA, and Accenture. Past Experience : - I am having 8+ years of combined experience in Regulatory Affairs + Clinical Research + Medical Affairs - guiding sponsors from first-in-human to post-market. - I help in formulation of Dietary Supplements in US, EU, India. - I help biotech and pharma teams design inspection-ready studies, secure ethics approvals, and deliver submissions that move programs forward on time and audit-proof. - MDR/IVDR support, Clinical Evaluation Reports, Performance Evaluation Reports, and technical file documentation. - I perform Regulatory gap assessments, audit readiness, health authority response support, and compliance strategy. Expertise on : USFDA • EMA • CDSCO I support IND/CTA/NDA submissions, eCTD documentation, labeling compliance, QA workflows, and clinical writing across startups, CROs, and emerging biotech teams. My focus is delivering accurate, inspection‑ready documents that accelerate development timelines without compromising compliance. What I Deliver : - IND, CTA, NDA, and ANDA module writing, particularly for CTD Modules 2 to 5. - Submission Preparation : eCTD support (Modules 1–5) - Labelling : US Prescribing Information, SmPC, CCDS review, labeling compliance, and content alignment. - SOP development, QA documentation, CAPA logs - Regulatory Writing : Clinical writing: Protocols, IBs, CSRs, safety summaries - Regulatory intelligence & documentation QC - Variation Preparation & Renewal Analysis (US & EU) Why Clients Work With Me : - RAC (US,EU, Global) certified - Strong foundation in FDA, EMA, HC, and ICH frameworks - High accuracy, fast turnaround, and structured workflows - Experience validating regulatory datasets used in AI systems - Ability to produce submission‑ready content across drugs, biologics, and devices If you need support preparing a submission, reviewing labeling, drafting SOPs, or QC‑checking regulatory documents, I can step in immediately and deliver with precision. Send me a message with your project details - I typically respond within a few hours. Also, If your regulatory documentation needs to be ready for submission and not sent back for repeated revision, share your project brief. I can help turn complex regulatory content into a strong, well-structured submission package. Keywords : Regulatory Affairs • IND/IDE • 510(k) • SaMD • ICH-GCP • IRB • Clinical Trial Design • Protocol Development • Pharmacovigilance • Medical Writing • CSR • IB • EDC/CRF • EMA • CDSCO • US FDA • 505 b(1) • 505 b(2)

Secondary search, clinical trials, pharmacology, pharmacovigilance, medical information, cost effectiveness analysis and Health economic and outcomes research work. PSUR and DSUR Writing. Icsr processing. IVDR Vigilance. Signal management, regulatory compliance for new pv software. GXP and 21 CFR compliance

✔ Accuracy ✔ Quality ✔ Satisfaction ✔ Quick response If you're in search of a reliable freelancer motivated by results, your search ends here. Let's team up to transform your goals into accomplishments. I'm Mamta Sahu, a highly motivated and versatile freelancer with 2 years of experience in the pharmaceutical industry as a Pharmacovigilance specialist. In my role, I have been responsible for conducting quality reviews of cases, performing data entry in the Sapphire Database, crafting descriptive narratives, assisting in reconciliation processes, driving case closure, coordinating translations and ensuring timely report submissions to clients. I have fluency in English language and also have knowledge of German A2 level. I am Commitment and dedicated to helping my client to achieve project goals with high-quality and within deadline . I am also a dedicated and skilled 𝑷𝒐𝒘𝒆𝒓 𝑩𝑰 𝒂𝒏𝒅 𝑬𝒙𝒄𝒆𝒍 𝑺𝒑𝒆𝒄𝒊𝒂𝒍𝒊𝒔𝒕. With hands-on expertise in transforming raw data into actionable insights, I offer a strategic approach to data management and visualization, helping clients make informed, data-driven decisions. I bring a unique blend of data analytics and business intelligence proficiency, empowering businesses to enhance their reporting capabilities and identify growth opportunities. My Expertise with which I can help my clients: ➤ 𝐃𝐚𝐭𝐚 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭: ✤ Data Entry ✤ Data Extraction ✤ Data Mining ✤ Data Scraping ✤ Data Collection ✤ Data Research ✤ File and Data management ✤ Canva 𝐏𝐨𝐰𝐞𝐫 𝐁𝐈 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬: ✤ Dashboard Creation ✤ Data Modeling ✤ Custom Visuals & Reports ✤ Power Query ✤ DAX Functions ✤ Real-Time Data Analysis ✤ Report Automation ➤ 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐀𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞: ✤ Editing and Proofreading ✤ Quality Control & Quality Assurance ➤ 𝐀𝐝𝐦𝐢𝐧𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐯𝐞 𝐒𝐮𝐩𝐩𝐨𝐫𝐭: ✤ Virtual Assistant Activities ✤ Administrative Support ➤ 𝐅𝐢𝐥𝐞 𝐚𝐧𝐝 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭 𝐇𝐚𝐧𝐝𝐥𝐢𝐧𝐠: ✤ File Conversion (various types) ✤ PDF Conversion & PDF Data Extraction ✤ Typing ➤ 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐚𝐧𝐝 𝐈𝐧𝐭𝐞𝐫𝐧𝐞𝐭 𝐏𝐫𝐨𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲: ✤ Internet Research ✤ Web Research ✤ LinkedIn Search ➤ 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐂𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐞: ✤ Microsoft Office Tools ✤ Google Docs ✤ Sapphire database ✤ Computer skills ➤ 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲: ✤ Pharmaceutical Proficiency ✤ Pharmacovigilance ✤ Medicines expertise ✤ Clinical And much more… I am enthusiastic about the prospect of collaborating with you on your projects, and I am confident that my skills and dedication will bring substantial value to your endeavors. Let's join forces to achieve success! Don't hesitate to reach out today, and let's kickstart the journey to make your projects a resounding success! I look forward to the opportunity to work together and make a positive impact. 𝓨𝓸𝓾𝓻 𝓖𝓸𝓪𝓵𝓼, 𝓜𝔂 𝓜𝓲𝓼𝓼𝓲𝓸𝓷 - 𝓛𝓮𝓽'𝓼 𝓪𝓬𝓱𝓲𝓮𝓿𝓮 𝓽𝓸𝓰𝓮𝓽𝓱𝓮𝓻 Kind Regards, Mamta Sahu.

CAREER GOAL:- To become a successful professional in the field of Pharmaceutical Sciences by utilizing my skills and to work in an innovative, challenging, and competitive environment to make full use of my strengths and knowledge. Professional : • M Pharmacy (Pharmaceutical Sciences), Koringa College Of Pharmacy, Andhra University, 2011-2013 • B Pharmacy, Koringa College Of Pharmacy, Andhra University, 2007-2011 Educational : • Schooling, SSC, Universal Public School, 2004-2005 • Intermediate, Bi.P.C, Sri Chaitanya Junior College, 2005-2007 Professional Experience: • Experience as a Pharmacist for three years near Alipuram, Visakhapatnam, Andhra Pradesh Achievements: • University Topper in B pharmacy 1st Year Strengths : • Fair communication skills • Hardworking • Ability to grasp quickly • Positive Attitude • Honest

Passionate about optimizing patient outcomes through strategic drug management and active pharmacovigilance. My background includes monitoring medication therapy, preventing drug-drug interactions, and reporting adverse events with precision. I am highly efficient in Microsoft Office, using Excel and Word to streamline clinical workflows and document patient care plans. I aim to combine my pharmacological knowledge with organizational excellence to improve healthcare delivery systems. I am also a highly organized and detail-oriented professional with a strong foundation in data management and technical communication. Beyond my clinical training, I specialize in leveraging Microsoft Office (Excel, Word, PowerPoint) to streamline workflows and analyze complex information. I pride myself on being a proactive problem-solver and an adaptable communicator, capable of managing high-priority projects with precision and efficiency.

Ph.D. in Pharmacology with research experience in both preclinical and clinical fields. Author of more than 10 articles in reputed peer review journals. Experienced NLP data annotator and researcher I work quickly and efficiently, with an eye toward guidelines and requirements of the project at reasonable prices. Client satisfaction and quality work are my utmost priorities.