Hire the Best Pharmacovigilance Freelancers
in India

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

I’m a Senior Medical Writer and Pharmacovigilance Expert with over 10 years of experience supporting pharmaceutical companies and CROs in navigating complex regulatory requirements. I specialize in signal evaluation and detection, including systematic literature reviews, development of search strategies, and analysis of line listings to identify and resolve discrepancies. I ensure all documents are accurate, consistent, and audit-ready, while managing end-to-end coordination, stakeholder communication, and timely submission to health authorities. My expertise includes the preparation and quality control of aggregate reports such as PBRERs, DSURs, INDSRs, RMPs, ACOs, PADERs, and addendum reports. I also have strong experience in signal management activities (SER/DSR), case and context evaluation, and periodic review of literature and safety data. I am proficient in using safety databases and tools for signal detection and have extensive experience performing QC of Drug Safety Reports, Clinical Overviews, Safety Evaluation Reports, health authority responses, Risk Management Committee documents, and ICSRs across all case types. I bring in-depth knowledge of global pharmacovigilance regulations, including ICH guidelines, EU GVP modules, FDA requirements, and CIOMS standards. In addition, I have hands-on experience in literature screening for identifying ICSRs from published data. I am also actively involved in training and mentoring team members, ensuring consistent quality and regulatory compliance across deliverables. I prioritize clear communication, technical accuracy, and high-quality outputs tailored to client needs.

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

I’m Dr. Abhijath - a Top Rated Plus Freelancer with $100K+ earned on Upwork, helping pharma, biotech, medical device, and dietary supplement companies with Regulatory Affairs, FDA submissions, product formulation, and clinical/medical documentation. I specialise in Regulatory Affairs for Drugs & Medical Devices and also work as a Drug & Dietary Supplement Formulation Expert. I’m a Pharm.D with a postgraduate qualification in Regulatory Affairs and currently work as a Regulatory Lead (Contract) on U.S.-focused programs. If you’re developing a pharmaceutical, biotech, nutraceutical, dietary supplement, or medical device product, I can help you turn the science behind it into a clear, compliant, submission-ready and market-ready package. My experience across Regulatory Affairs, Clinical Research, Medical Affairs, Pharmacovigilance, and formulation science allows me to look beyond just one document. I understand how the product, clinical evidence, formulation, claims, labeling, regulatory strategy, and submission documentation need to work together. Clients typically hire me for: • U.S. FDA regulatory strategy and submission support • IND, NDA, ANDA and CTD/eCTD documentation • Pre-IND preparation and FDA correspondence • Regulatory, clinical, CMC and medical writing • Protocol, Investigator’s Brochure and Informed Consent Form review • Dietary Supplement & Nutraceutical Formulation - U.S., EU & India • Ingredient selection, scientific rationale and formulation optimization • Supplement claims, labeling and technical documentation • Medical Device 510(k) regulatory support• EU MDR & IVDR documentation • Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) • Medical Device technical documentation and regulatory gap assessment • Clinical research, ethics and IRB submission support I focus on understanding what you are trying to develop, where you want to market it, what regulators will expect, and what needs to be done to get there. You’ll get clear communication, practical recommendations, scientifically defensible documentation, and work developed with regulatory review in mind - not simply documents created to complete a checklist. Whether you are preparing an FDA submission, developing a new supplement formulation, starting a clinical program, or bringing a medical device to market, I can support you from strategy through execution. Have a regulatory or product development challenge? Send me a message and let’s discuss the best way to move your project forward. Areas of Expertise : Regulatory Affairs | FDA Compliance | FDA Regulatory Consulting | IND | NDA | ANDA | 505(b)(2) | CTD | eCTD | CMC | Regulatory Writing | Medical Writing | Clinical Research | Clinical Trial | Protocol Development | Investigator’s Brochure | Dietary Supplements | Nutraceutical Formulation | Product Formulation | Supplement Formulation | FDA Labeling | Regulatory Compliance | Medical Devices | 510(k) | EU MDR | IVDR | Clinical Evaluation Report | Performance Evaluation Report | Technical Documentation | Pharmacovigilance

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.

A pharmacist with over 3 1/2 of research and clinical application experience. I am trained and licensed to provide expertise in pharmacy, pharmaceutical sciences, pharmacovigilance, pharmacology, clinical outcomes, biology, biochemistry, and genetics. I am detail oriented, adaptable, dependable and most importantly passionate about patient care and the profession of pharmacy. I am also technologically savvy, fluent in PC applications and have the ability to utilize professional clinical tools and top databases (PubMed, Clinical Pharmacology, Natural Medicines, etc.). Invested in carrying out research and in-depth analysis to provide evidence and insights that feeds healthcare decisions, pharma business output and regulatory decisions. Particularly skilled in secondary research on medical literature databases, clinical trial research (Analyzing clinical trials from journals, meeting abstracts, presentations, clinicaltrials.gov and providing valuable information to bio-pharmaceutical companies.), systematic literature reviews, medical writing, pharmacovigilance reports and project management. Expert in tracking regulatory filings and analyze the regulatory information using data sources like SEC files, annual reports, FDA, EMEA & other regulatory websites, abstracts, journals, conferences & events. Performed all data management tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and client) are achieved.  Performed reconciliation of the clinical database against safety data, laboratory data, ECG, PK and other third-party data as appropriate  Reviewed clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data  User Acceptance Testing (UAT)  Participated in Internal Core team and Client meetings and supports the Lead Data Manager with risk management on allocated projects. . I pay adequate attention to all my projects so deliverables are developed excellently and completed in a timely manner thanks to my years of research, medical writing and project management. I am very efficient, organized and result oriented. Feel free to contact me if you require my services. I look forward to working with you.