Experience

Adveesan Pharma Consulting

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief Clinical Development Expert and Founder

  • Mar 2018 - Present

  Mumbai Area, India Adveesan Pharma Consulting is a Global Regulatory, Pharmacovigilance and Clinical Development Consultancy based at Amsterdam; Netherlands and Mumbai; India. Adveesan has expertise in area of Global Regulatory strategies, Documentations, Submissions and Life Cycle Management of Drugs, Vaccines and Device. Adveesan has also expertise in area of Global Pharmacovigillance requirement along with Europe QPPV services and case processing. Company also provides service into Clinical… Show more Adveesan Pharma Consulting is a Global Regulatory, Pharmacovigilance and Clinical Development Consultancy based at Amsterdam; Netherlands and Mumbai; India. Adveesan has expertise in area of Global Regulatory strategies, Documentations, Submissions and Life Cycle Management of Drugs, Vaccines and Device. Adveesan has also expertise in area of Global Pharmacovigillance requirement along with Europe QPPV services and case processing. Company also provides service into Clinical Development strategies for generic, modified generics, bio-similar, biotech, vaccines products along with Medical Writing Documentations. Show less



SciRx Communications Pvt Ltd

• India
• Advertising Services
• 1 - 100 Employee

• Director- Medical Content , Co-founder

  • Apr 2016 - Present

  Mumbai Area, India SciRx Communications Private Limited is a Pharma and Healthcare communications organisation. SciRx adds immense value to enhance the brand value and recall by bringing in novel concepts, ideas, innovations and strategies. We would like to be associated with Pharma and healthcare sector as their strategic and scientific think-tank partners to bring in an unique edge thereby strengthening the armamentarium of a pharma brand manager.



ASK-CRE PVT LTD

• Head- Medical Services and Regulatory Affairs, Co-Founder

  • Jul 2015 - Mar 2018

  Mumbai Area, India



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical and Safety Head- Respiratory Global Clinical Development

  • Jun 2014 - Jul 2015

  Mumbai Area, India I lead the teams for Clinical Strategy, Medical Writing and Safety (Medical Monitoring) of Respiratory Therapeutic Area for Regulated Markets. Clinical Strategy: • Review of Clinical strategy • Review of Clinical Development plans and approval of budget • Prepare and review of scientific advice/briefing package documents • Prepare and review regulatory responses • Track and manage program budget • Resource Tracking • Develop and impart training for program… Show more I lead the teams for Clinical Strategy, Medical Writing and Safety (Medical Monitoring) of Respiratory Therapeutic Area for Regulated Markets. Clinical Strategy: • Review of Clinical strategy • Review of Clinical Development plans and approval of budget • Prepare and review of scientific advice/briefing package documents • Prepare and review regulatory responses • Track and manage program budget • Resource Tracking • Develop and impart training for program managers Medical Writings: • Review of all key documents like Protocol, Study reports, Investigator Brochure, Clinical overview and Summaries, • Resource allocation as per program and project requirement • Training of Medical writers • Resource tracking Medical Monitoring • Medical review of Protocols • Inclusion Exclusion criteria for clinical trials • Medical monitor for global clinical trials • Safety Management Plan preparation Show less



ELC Group

• Senior Medical Expert

  • Oct 2012 - May 2014

  Prague, The Capital, Czech Republic I am responsible for all activities under Medical Team like Medical Writing, Clinical Advise, Scientific Advise, Clinical review etc. The 95% of the work is for EMA and EEA national regulatory Agencies. - Responsible for preparing Scientific Advise Documents - USFDA and EMA - Responsible attending Meetings with EMA and EEA national regulatory agencies - Review of agencies Assessment Report and advise to clients for further development strategies - Preparing Clinical development… Show more I am responsible for all activities under Medical Team like Medical Writing, Clinical Advise, Scientific Advise, Clinical review etc. The 95% of the work is for EMA and EEA national regulatory Agencies. - Responsible for preparing Scientific Advise Documents - USFDA and EMA - Responsible attending Meetings with EMA and EEA national regulatory agencies - Review of agencies Assessment Report and advise to clients for further development strategies - Preparing Clinical development Strategy and Clinical Development plans - Responsible for Medical writing Team Management - Responsible for Regulatory Medical Writing deliverable- Protocol, CSR, RMP, CTD Modules etc - Responsible for Clinical Advise to clients based on Scientific and Regulatory requirements - Responsible for GCP audits and Training - Providing Clinical Support to Pharmacovigillance Team - Provide Technical Support to Business Development Team Show less



USV PRIVATE LIMITED

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager - Clinical Research

  • Feb 2012 - Oct 2012

  Mumbai Area, India I looked after complete Clinical Development of Biosimilar Molecule. Deciding strategy, protocol designing, execution of clinical trial in India & Regulatory Market. -Deciding Strategy for Clinical Development -Preparing Clinical Development Plans -Preparing and Review of Scientific Advise Documents for USFDA and EMA -Attending Scientific Advise Meeting with USFDA and EMA for Protocol Discussion -Attending NDAC meeting with DCGI ( Indian Regulatory Agency) for protocol… Show more I looked after complete Clinical Development of Biosimilar Molecule. Deciding strategy, protocol designing, execution of clinical trial in India & Regulatory Market. -Deciding Strategy for Clinical Development -Preparing Clinical Development Plans -Preparing and Review of Scientific Advise Documents for USFDA and EMA -Attending Scientific Advise Meeting with USFDA and EMA for Protocol Discussion -Attending NDAC meeting with DCGI ( Indian Regulatory Agency) for protocol approval and CSR submission. -Medical Monitoring of Bio-similar and Bio-equivalence Trial -Preparing and Reviewing of Regulatory Medical Writing Documents like Protocol, CSR, IB etc -Managing CROs- Identification, selection and audit of the CROs on project basis Show less



Dr. Reddy's Laboratories

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Dy. Manager Medical Sciences -Clinical Development, Biologics Development Centre,

  • May 2010 - Jan 2012

  Hyderabad Area, India • Acting as a medical writer for regulatory submission documents. • Managing and tracking all medical writing related work • Identification and managing CRO and or consultants for Medical Writing • Tracking Deliverables, contacts and payments of CROs • Coordinating for internal review of documents • Creating internal review process of medical writing • Acting as a connect with internal project management team. • Acting as a connect for Regulatory affairs team for regulatory… Show more • Acting as a medical writer for regulatory submission documents. • Managing and tracking all medical writing related work • Identification and managing CRO and or consultants for Medical Writing • Tracking Deliverables, contacts and payments of CROs • Coordinating for internal review of documents • Creating internal review process of medical writing • Acting as a connect with internal project management team. • Acting as a connect for Regulatory affairs team for regulatory documents review • Maintaining the TOC for all molecule for alliances management. • Preparation of Medical writing SOPs, • Preparation of Medical writing Process Maps Show less



Tata Consultancy Services

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Senior Regulatory Medical Writer- TCS-GSK Global Development Centre, Mumbai

  • Jan 2007 - May 2010

  Mumbai Area, India • Initiate start up meetings with the Study Teams in GSK related to the creation and development of the clinical document for regulatory submission. • To work in co-ordination with all the members in the study team- internal and external for the development of clinical trials documents. • Project timelines amongst the study team for the development of study. • Ensure Clinical co-ordination activities are performed according to estimated timelines and documented guidelines. • Ensure… Show more • Initiate start up meetings with the Study Teams in GSK related to the creation and development of the clinical document for regulatory submission. • To work in co-ordination with all the members in the study team- internal and external for the development of clinical trials documents. • Project timelines amongst the study team for the development of study. • Ensure Clinical co-ordination activities are performed according to estimated timelines and documented guidelines. • Ensure quality documents that objectively and accurately represent the data. • Write scientific documents for regulatory submissions like: o Clinical Study Reports o Investigators Brochure o Clinical pharmacology study report (CPSR) o Clinical trial registry (CTR) summaries o Patients Narratives o Clinical Study protocol o IND/NDA annual reports o Post approval documentation o Other regulatory submission documents • Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. • Reviews statistical analysis plans and table/figure/listing. • Ensure uniformity and consistency in the scientific content of the regulatory documents. Show less



Nicholas Piramal India Ltd

• Principal Investigator

  • Jan 2005 - Jan 2007

  Mumbai Area, India • Deciding BE study strategy as per FDA,WHO and EMEA requirements • Designing Clinical Study Documents • Project Coordination / Clinical Operations • Data analysis and Report Writing • Review of PK and Statistical Data • Audit preparation and Training