Sharanya Nair

A Regulatory affairs associate and a Medical Writer with over 6 years of extensive experience working with multinational and pharmaceutical companies like Inter-scientific, Accenture Solutions Pvt. Ltd., and Pfizer Healthcare India Pvt. Ltd. Consistently demonstrated a high level of accuracy and integrity in professional assignments with the focus on safety narrative writing, aggregate reporting, and medical writing for various nonclinical and clinical regulatory submissions. The specialization includes collecting and analyzing data, processing, creating and maintaining records, and developing regulatory strategies to complete the task in a team environment. Also proficient in handling multiple tasks efficiently and accurately by prioritizing the work. Being a motivated and articulate Professional with a passion for excellence, I am looking for a challenging role in the pharmaceutical industry or a multinational company where opportunities for growth and success are unlimited.

Regulatory Affairs Associate (21 February 2023 to present) Inter Scientific-Garston, Liverpool, United Kingdom • Drafting and proofing of documents. • Drafting of Cosmetic Product Safety Reports (CPSR). • Drafting of toxicological reports for TPD (Tobacco Product Directive) submissions. • Completing UFI/ PCN (Person Centre Notification) notifications. • Working on MSDS (Master Safety Data Sheet). • Tobacco Products Directive (TPD) notifications. • Communicating with clients and suppliers. • Completing training as directed by Manager. • Gaining knowledge of the company EQMS and working according to procedures • Helping in other business areas (cosmetics, other vaping products and medical devices if requested). Senior Medical Writing Associate (16 September 2021 to 27 August 2022) Accenture Solutions Pvt. Ltd – Chennai, India Safety Narrative Writing • Collect, monitor, research, assess and evaluate information on the adverse effects of medication to identify new information about hazards associated with medicines and consequently prevent harm to patients. • Conduct analysis of singles cases extracted and clinical submission narrative writing for Phase 1-4 clinical trials in accordance with client SOP. Narratives must be written based on data listings and/or safety reports. • Writing, Reconciling, editing and/or managing the production of high-quality clinical documents. • Ensure consistency with quality, accuracy, and medical safety standards. • Design and maintain a safety database to monitor single case support activities. • Oversee execution of Quality Control and discrepancy management for outputs. • Assist in training for new resources and as a part of continuous improvement. • Assist in developing documentation such as work instructions or task checklists for readiness activities as required. • Ensure compliance with client and company policies. • Own assist and comply with all SLAs (Cycle time and quality). Executive-Regulatory Writing and Submission Scientist, (27 February 2017 to 12 September 2021) Pfizer Healthcare India Pvt. Ltd – Chennai, India • Aggregate Reporting  Responsible for nonclinical sections of Annual and Aggregate reports (NDA, PSUR, DSUR, SUR, PBRER and ACO).  Performing literature reviews for nonclinical literature and finding out any possible safety information and periodic review of sponsor-initiated studies and continuous analysis of relevant non-clinical safety information.  Raising attention for articles containing any safety findings of interest to Subject Matter Experts, RSLs, and/or PDM scientists for evaluation of importance or potential importance to the known safety profile of the product and to provide a response to WSR within the designated due date.  Upon getting confirmation from the Subject matter experts, the new safety findings are documented in the Global Document Management System and ordering complete publication and retrieving articles in case, if required, to assess the credibility of data to the e-library services.  As Regulatory Writer:  Work in Liaison with Drug Safety Research& Development (DSRD) and Regulatory Strategy Leads and Medicine Design/PDM colleagues to prepare and support regulatory dossiers' expert nonclinical sections of eCTD documents (pharmacology/ADME/toxicology) and investigators brochures and oversee the integration of all nonclinical contributions.  Support global regulatory dossier and query response preparation in collaboration with the Regulatory Strategy Leads (RSLs) and/or PDM scientists and oversee the timelines and reviews associated with nonclinical summary documents.  Liaise with WSR to prepare and review correspondence related to nonclinical queries and support nonclinical sections in support of product license renewals.  Serve as an information resource and point of contact, provide user training and support for new and existing document management tools, and provide continuity of experience and history of practice for document management and submission processes.  Quality Reviewer:  Responsible for quality review of content for accuracy, correctness, consistency, and submissionready formatting, compilation, and compliance of the dossier according to international standards, Global Style Rule Book and Style Guide, and PREDICT templates.  Document management support for submission-level documents and study reports includes o Organizing and formatting submission-ready documents and files for regulatory submissions (Nonclinical Overview, Nonclinical Tabulated Summaries, Nonclinical Written Summaries, and Study Reports). o Working within Global Document Management System (GDMS) to manage document preparation, review, and approval. o Requesting, compiling, and verifying published literature references. Supporting incorporation of CRO study reports into GDMS.

PharmD (Doctor of Pharmacy)