Pushkar Shrinivas

Experience

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  Alkem Laboratories Ltd.

  Jul 2016 - Mar 2017

  Clinical Research Associate
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  Zydus

  Mar 2017 - Jul 2020

  Senior Executive Pharmacokinetics- Transdermal drug delivery systems

   Currently working in a Clinical research and Pharmacokinetic Division with handling of various projects of novel drug delivery systems like TDDS (Transdermal Drug Delivery Systems) and Topicals for US market. Preparing study design of specific study like adhesion/ irritation and BA/BE studies of TDDS or Topical products. Preparing of protocols and Performing and handling various activities like adhesion/Irritation observations, analyzing scoring data of the subjects records for in-house adhesion/Irritation studies. Reviewing of protocols of specific studies like adhesion/Irritation and BA/BE. Communication with CRO for clinical study related activities and Monitoring of studies nationally and internationally Monitoring of the adhesion/irritation and BA/BE studies and Verification of the all study related documents like IEC approval documents, screening records of volunteers, ICF presentation & documentation records, CRF, & IP accountability record etc., according to the regulatory requirements of agency. Evaluating and analyzing of adhesion & irritation data score using statistics to draw conclusion for the inferiority of the product. Evaluation of Bio equivalence results and comparing it with in-vitro testing data Preparation and maintaining the records of summary report of the monitoring of adhesion & irritation study for in-house as well as outsourced studies Reviewing Adhesion and Irritation and BE Reports as per regulatory requirements Providing training related to the product applications prior to study initiation as per product specifications Handling various activities to get approval from the DCGI in order to conduct the study in India. Handling various study related queries form the regulatory agencies. Specialities: Clinical research, Medical writing, Drug Discovery and Development, Pharmacovigilance. Show less

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  SUN PHARMA

  Jul 2020 - Nov 2022

  Senior Clinical Research Scientist- Pharmacokinetic
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  Sandoz

  Nov 2022 - now

  Clinical Development Associate

   Review of the literature to understand the rationale of bioequivalence/clinicalstudies. Strategy preparation for- 505(b)(2)/505(j) submissions. Designing, planning and conducting of the bio/clinical studies for various dosage forms. Protocol development and submission for regulatory approvals. Development of ICF, CRFs and Clinical trial related documents. To perform and interpretation of Pharmacokinetic results using Phoenix WinNonlin®. Review of clinical study report (eCTD) dossier as per the regulatory requirement. To avail BE-NOCs and/or BE-TL from DCGI for conduct of BA/BE studies. Handling of regulatory deficiencies with suitable scientific justification. Preparation of control correspondence to the Agency for critical aspects. Co-ordination with CROs (national and international CROs) for designing, planning andexecution of clinical studies. Perform monitoring of the bio-studies/clinical centers. Managing complete outsourcing of the clinical studies and Project Management. Development of Clinical Pharmacology and Pharmacokinetics department SOPs. Investigational products management and shipment as per the standards at Clinical sites. To work on feasibility and selection of CRO. To work closely with product development teams and other internal stakeholders in the product development.Skills and Competencies: PK analysis using Phoenix WinNonlin. Understanding of Statistical Analysis by SAS software. Clinical Monitoring and Project Management. Mentorship. Show less