Experience

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  Biopta

  Feb 2008 - Sept 2008

  Research associate

  • handling of human and animal tissues.• preparation of informed consent forms.• good laboratory practice (glp), adherence to ich-gcp guidelines, and care and handling of substances hazardous to health (coshh).• calibration, operation, and maintenance of laboratory equipment's (myographs, organ baths, centrifuges, titrators, pipettes, and ph meters).• data analysis, report preparation and presentation to wider audience.

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  Abc pharmacy ltd. london

  Sept 2008 - Oct 2010

  Pharmacytechnician

  • dispensing and labeling of medications, to ensure patient safety.• prescription handling, patient database management, patient counseling and collaboration with healthcare practitioners.

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  Central drug standard control organisation

  Jan 2011 - Jul 2011

  Technical associate (pharmacovigilance)

  • led setting up of a regional pharmacovigilance center at the pvpi-identified government medical college contributing to nationwide safety surveillance.• reported icsr's to pvpi coordinating center (pvpi national co-ordination centre) using vigiflow, ensuring accurate and comprehensive data.• meddra / who drug dictionary coding.• quality review of adr forms and provided training and feedback to physicians through newsletters circulated by pvpi national coordinating centre.

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  Sciformix

  Jul 2011 - Sept 2013

  Medical writer

  • authoring and review of aggregate safety reports (pbrer, psur, pader, dsur, car, aco and summary bridging reports).• reports management process: tracking, planning, generating line listings using argus and aers databases, report preparation, peer review, submission review, quality control, client management, submission to the usfda, and training & mentoring of team members.• preparation of labeling justification documents (ljd) for submissions to regulatory agencies for supporting changes to ccds sections 4.8 and 4.9.• label update project: involved in updating current prescribing information in response to innovator labels for the us market.• narrative writing: supported the pharmacovigilance team by writing narratives for adverse drug reactions. show less

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  Springer nature in india

  Sept 2013 - Oct 2015

  Senior scientific and medical writer - i

  • authored drug development programs and updates for drug pipeline database for competitive/business intelligence and market analysis.• handled tracking of key global drug development programs - from discovery, through pre-clinical and clinical studies to launch (all therapeutic areas and indications).• reviewed published clinical studies, drug development programs from international journals, company media releases, company website, sec filings and abstracts from key international conferences, to write scientific results, including adverse events information (including pharmacokinetic and pharmacodynamic data). show less

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  Sciformix

  Nov 2015 - Jul 2017

  • signal management project: coordinated the team of medical reviewers and writers for signal detection activity. responsibilities included acting as poc for client, work distribution, metrics preparation/update, quality control and submission. • led process improvement activities, conducted trend analysis, capa management, training, audit, and inspection support.• regulatory intelligence: established the regulatory intelligence process, to keep track on global regulatory updates and performed gap-analysis for existing processes and procedural documents (e.g., process maps, sops, guidance documents etc.).• development of quality metrics and presentation at various forums (management and governance meetings). show less • performed review of various aggregate safety reports e.g., pbrers, paders, psurs, car and acos.• prepared quality metrics, to ensure deliverables meet agreed quality targets (sla/kpi).• involved in performing error trend analysis to identify process gaps and training needs.• provided periodic feedback and shared learnings with the teams.• carried out the monthly audit readiness activities and flagged critical issues that needed urgent attention.• audit and inspection support - internal and client audits, and supported clients for regulatory inspections.• deviation and capa management, training, process reviews, development of quality management plan, preparation and review of sops to ensure compliance with applicable regulatory guidelines.• ensured process compliance as per sops, client requirements/agreements and regulatory guidelines. show less

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  Covance

  Jul 2017 - Nov 2020

  Assistant manager, quality (scientific writing and regulatory affairs)

  • qms management: sop development, regulatory compliance check, audit & inspection readiness, training and feedback, metrics preparation, trend analysis, process improvements, regulatory intelligence (gap-analysis and impact assessment), monitored sla/kpi requirements (timelines, quality etc.), deviation and capa management, and change management across different projects in aggregate safety reports and regulatory affairs.• handled pv related processes, such as psmf, development/review of safety agreements, global reporting timelines, and regulatory submissions.• effectively communicated and escalated critical issues to management and clients, including presentation at governance meetings and interface with the qppv.• involved in inculcating the quality culture among teams to ensure they proactively assesses compliance issues and risks and follow mitigation plans.• supported audits and regulatory inspections, including planning, preparation, preparing responses to observations, followed up on audit responses and assisted in verifying capa effectiveness.• managed a team of experienced qa personnel to achieve highest standards of quality. show less

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  Eli lilly and company

  Dec 2020 - now

  • as a dedicated quality advocate, involved in collaborating with management and the quality team, to integrate robust quality practices into business processes across global regulatory affairs, periodic safety reporting, and scientific communications.• inspection and audit readiness: involved in routine inspections, self-inspections, and audits throughout the clinical development process. • involved in developing, publishing, training, implementing, and archiving sops and guidance documents.• provided inputs for audit and quality plans based on identified risks and gaps. resolving potential risks based on previous study results, audit findings, and routine quality management.• offered quality-related guidance to business units (regulatory affairs, periodic safety reports, drug safety, and scientific communication) to ensure compliance with external and internal requirements.• conducting procedural trainings and shared learnings from local audits and inspections to foster a culture of continuous learning.• implemented systems and tools related to operational tasks (e.g., rim, lms) to streamline processes and enhance efficiency.• analyzed quality data and performed trend analysis for process reviews and automation initiatives, contributing to overall quality enhancement.• quality metrics development and discussion at relevant forums. show less