Highlights:A spirited, team oriented medical writer with over 6+ years’ experience in scientific, regulatory and pharmacovigilance writing. Broad Drug Safety, Pharmacovigilance, and Bioscience experience Clinical research skills: •Basic pharmacology, including pharmacokinetics (ADME), drug toxicity testing and pharmacodynamics, clinical research methodology, GCP/ICH guidelines and CIOMS initiatives Pharmacovigilance and Drug Safety Skills: • Knowledge and experience of EU Pharmacovigilance Regulations • Experience in writing of PSURs/PBRERs (main focus: signal and risk evaluation, benefit analysis, integrated benefit-risk analysis), DSURs, summary bridging reports, safety clinical narratives • Experience in maintenance of Pharmacovigilance System Master File (PSMF) • Experience of Risk Management (Identifying potential risks, Pharmacovigilance Plan, minimisation of risks), Signal Detection, Safety Labeling Regulatory/Scientific Medical Writing Skills: Experience in writing of clinical study reports, clinical trial documents, research protocols, SOPs, scientific manuscripts, medical literature, publication support, newsletters, monographs, interpreting and summarising statistical data, and editing/proofreading of scientific articles, critically analyses of safety and scientific data Background of rich research experience in pre-clinical settings and have authored four research publications Therapeutic areas: Oncology, Diabetes, Immunology, Infection (HIV), Cardiovascular, Neuroscience, Orthopaedics, and Paediatrics EXPERIENCE: Consultant Medical Writer, Eisai Europe, Oncology Business Unit, Hatfield, UK (May 2017-Till Date) Lead DSUR Coordinator- Cognizant Services-Novartis Oncology Submission Group, Switzerland and India (May 2016-Sept 2016) Regulatory Medical Writer, PAREXEL International, Uxbridge, UK (June 2013 April 2016); Clients worked: Sanofi Aventis, Pfizer, Janssen, Ipsen projects for multiple clinical study documents in Diabetes and Neuroscience Therapeutic Area Scientific Writer- Pharmacovigilance (Contract), Roche Pharmaceuticals- Hays Life Sciences, UK (May 2012-October 2012) Medical Writer (Contract) - Hays Pharma, Switzerland; Client: Smith & Nephew Orthopaedics AG (March 2011-August 2011) Freelance Medical Writer and Clinical Project Assistant, Obesity Management Clinic, Mumbai, India (May 2010-Jan 2011) Medical Writer and Editor, Cactus Communications, Editage Division (Medical Communication Agency) (Nov 2009-May 2010) Clinical Project Intern- MSc project- (Translational Medicine) - Primrose Oncology Research Unit, Bedford Hospital, Bedford, UK (April 2009-Sept 2009) Senior Bioscience Faculty, Triumphant Institute of Management Studies, Bangalore, India (Feb 2006-Feb 2007) Research Fellow, Radiation Biochemistry Division, Bhabha Atomic Research Centre, Mumbai University, India (May 2000-June 2005)

Skills:medical writer

Goal:A spirited, team oriented medical writer with over 6+ years’ experience in scientific, regulatory and pharmacovigilance writing. Broad Drug Safety, Pharmacovigilance, and Bioscience experience Looking for challenging opportunities in Clinical Medical Writing, Regulatory Writing, Pharmacovigilance Medical Writing

Honor:Junior and Senior Research Fellow Ship (2000-2005) in Radiation Biochemistry- Bhabha Atomic Research Centre, India

Consultant Medical Writer 05/2017 - current
Eisai Europe, Oncology Business Unit, Hatfield, UK, London, United Kingdom
Industry: Pharmaceutical
Working directly with clinical study teams, the oncology and neuroscience medical writing teams, regulatory affairs personnel, and the publishing group for preparation of documents such as protocols, protocol amendments, CSRs, and Global Investigator Brochures, and PV documents
• Working directly with clinical study teams, the oncology and neuroscience medical writing teams, regulatory affairs personnel, and the publishing group for preparation of documents such as protocols, protocol amendments, CSRs, and Global Investigator Brochures • Drafting of DSURs, PSURs, and assisting PV team for RMPs for drugs- Lenvatinib and Eribulin • Drafting of EMA and FDA response sponsor briefing document for Lenvatinib for Hepatic Cell Carcinoma • Responsible for managing the document review process and route the document for approvals • As representative of core oncology medical writing group, act as liaison between the UK team and the MW group and vendors based in US--
Lead DSUR Coordinator 05/2016 - 09/2016
Cognizant Services-Novartis Oncology Submission Group, Switzerland and India, , United Kingdom
Industry: CRO-Pharma
Lead DSUR and PSUR writer involved in drafting, scientific review, and QC of DSURs/PSUR for Novartis Oncology Submission Group.
• Drafting, scientific review, and QC of DSURs for Novartis Oncology Submission Group. • Coordinating and managing the entire DSURs process: Scheduling and leading a kick-off meetings, request author contributions from the client, draft DSURs based on the E2F guideline, drive review comment resolution meetings, provide relevant information from the DSUR for PBRER preparation, finalization of DSURs within the agreed timelines. Case Processing: To assess a safety signal, a drug-event association and the overall benefit risk balance--
Regulatory Medical Writer 06/2013 - 04/2016
PAREXEL International, Uxbridge, UK, London, United Kingdom
Industry: CRO
Research, create, edit and quality control of clinical documents, including clinical study reports, protocols, investigator brochures, clinical trial documents modules (2.7.3, 2.7.4), integrated safety summary report, DSURs, PSURs, model informed consents, patient narratives
• Research, create, edit and quality control of clinical documents, including clinical study reports, protocols, investigator brochures, clinical trial documents modules (2.7.3, 2.7.4), integrated safety summary report, DSURs, PSURs, model informed consents, patient narratives • Assist writing in various sections of PSUR (signal and risk evaluation, benefit analysis, integrated benefit-risk analysis sections) • Evaluation of case reports to assess and re-confirm SAEs, life threatening events, deaths, and other AE of clinical significance • Perform quality control of documents by providing medical edit, review of draft and final documents prepared by other writers before internal or external distribution • Planning work plans and timelines for individual medical writing deliverables, identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options • Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines--
Scientific Writer- Pharmacovigilance (Contract), 05/2012 - 10/2012
Roche Pharmaceuticals, London, United Kingdom
Industry: Pharmaceuticals
: 1) Writing and maintenance of Pharmacovigilance System Master File (PSMF) based on new PV EU legislations and GVP guidelines 2) Drafting PSMF SOP and supporting documents to facilitate internal training 3) PSUR/PBRER submission tracking and creating metrics/compliance data for QPPV office
• Prepare project plan and timelines for drafting and submission of PSMF • Write, edit, and perform quality check of all sections of PSMF for accuracy, completeness and compliance with new GVP and EU PV Legislations guidelines, within scheduled timelines • Collect/request data for PSMF from various stakeholders (Roche Global 87 affiliates- Local Drug Safety Responsible) and update with revised content as required • Perform final Quality Assurance and compliance checks by liaising with QPPV Office, publication team at India (TCS) before releasing the final PSMF online in RAPID • Draft PSMF SOP and supporting documents for internal training • Monthly maintenance of PSMF facilitating publication process and scheduling submission timelines • Collect/create/review PV relevant metrics/compliance and other relevant data (e.g., updates, presentations) to support oversight of PSUR • Assist in PSUR/PBRER submission tracking and prepare of quarterly MRP/NAP/CAP submission report--
Scientific Medical Writer-contractor 03/2011 - 08/2011
Smith & Nephew Orthopaedics AG, London, United Kingdom
Industry: Medical Device
Scientific Medical Writer for : "The Journey Deuce - Bi-Compartmental Knee System Project"
• Drafting, editing and referencing scientific publication in line with guidance from authors • Checking and editing documents to ensure accuracy • Assisting in preparation of patient education material on Bi-compartmental Knee Arthroplasty--
Freelance Medical Writer and Clinical Project Assistant (remote- India and UK) 05/2010 - 01/2011
Obesity Management Clinic, Mumbai, India, London/Mumbai, United Kingdom
Industry: Healthcare
Drafting of clinical reports for obesity management in 64 adolescent girls suffering from PCOD
• Project planning activities and schedule submission timelines • Draft and edit clinical study reports, research protocol • Write clinical summaries and patient narratives • Write patient education material for diabetes, obesity and fertility program--
Clinical Project Intern- MSc project- (Translational Medicine) 04/2009 - 09/2009
Primrose Oncology Research Unit, Bedford Hospital, Bedford, UK, Bedford, United Kingdom
Industry: Healthcare
Clinical Internship and writing for project: Finalisation of study design for a clinical trial protocol developed for testing a new cream for Hand Foot Syndrome (HFS) and Cold Sores
• Design and drafted ICH-compliant clinical research protocol clinical trial developed for testing new cream for Hand Foot Syndrome • Design and drafted ICH-compliant Clinical Study Report for clinical trial developed for testing new cream for Cold Sores • Draft Investigator’s Brochure, Patient Information Sheets, Informed Consent forms, Case Record Forms for the clinical trial • Draft patient narratives, clinical summaries, and report serious adverse events--
Medical Writer and editor 11/2009 - 05/2010
Cactus Communications, Editage Division (Medical Communication Agency), , Mumbai India
Industry: Healthcare/Medical Communication
Scientific and regulatory medical writing
• Lead author for clinical study reports, study protocols, patient narratives • Drafting scientific manuscripts, literature survey, research papers on broad therapeutic areas ICH, ICMJE and CONSORT guidelines • Designing slides, conference posters and patient educational materials • Editing, proof-reading, referencing, styling of manuscripts, and publication support • Managing multiple editorial projects to deadlines and keeping tracking documents up to date--
Senior Bioscience Faculty 02/2006 - 02/2007
Triumphant Institute of Management Studies, Bangalore, India, Bangalore, India
Industry: Education
Senior Bioscience teacher
• Designed, drafted, and edited course materials for Biology (GCSE level) • Imparted lectures in Biosciences.--
Research Fellow, Radiation Biochemistry Division 05/2000 - 06/2005
Bhabha Atomic Research Centre, Mumbai University, India, Mumbai, India
Industry: Bioscience Research
Senior research fellow working on understanding DNA damage by gamma radiations and DNA repair by radio modifiers using Yeast as a eukaryotic test system
Thesis Project: Regulation of radiation response, DNA damage and radioprotection in Yeast • The project involved evaluating the efficacies of non-toxic compounds to impart radioprotection to normal oxic cells during cancer radiotherapy, in the pre-clinical settings. PUBLICATIONS 1) P. Nemavarkar, K. Pasupathy, and K. Mishra, 2009. Radioprotective action of Trigonelline: Use of Saccharomyces cerevisiae as a test system. Indian J Radiat Res, 1; 29 2) P.S Nemavarkar, B. K Chourasia, and K. Pasupathy, 2004. Detection of gamma-radiation-induced DNA damage and radioprotection of compounds in yeast using Comet assay (SCGE). Journal of Radiation Research, Vol: 45, 169-174 3) P.S Nemavarkar, B.K Chourasia, and K. Pasupathy, 2004. Radioprotective action of compounds: Use of yeast Saccharomyces cerevisiae. Journal of Environmental Pathology, Toxicology and Oncology, Vol: 23 (2), 145-151 4) P.J Vaidya (Nemavarkar) and K. Pasupathy, 2001. Radioprotective action of Caffeine: Use of Saccharomyces cerevisiae as a test system. Indian. J. Exp. Biology, Vol: 39, 1254-1257--

Mumbai University 07/1994 - 06/1997
Mumbai, , India
Degree: Bachelor's Degree
Major:Biosciences
BSc in Biosciences- majors in botany and genetics

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