Open to opportunities

Pradeep Patil

@pradeeppatil

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Experienced Senior Biostatistician with a passion for clinical research.

India

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What I'm looking for

I am looking for a role that offers growth opportunities, a collaborative culture, and challenges that enhance my skills.

I am an experienced Senior Biostatistician with over 12 years of expertise in managing pharmacokinetic studies and collaborating on clinical research projects. My journey in the pharmaceutical industry has equipped me with a solid foundation in preparing Clinical Study Reports (CSRs) for various phases of clinical trials, ensuring compliance with regulatory requirements and guidelines such as ICH E3 and ICH GCP E6.

Throughout my career, I have honed my skills in medical writing, project management, and data presentation. I have successfully contributed to the preparation and review of essential documents, including study protocols, informed consent forms, and regulatory submissions in eCTD format. My experience with tools like Veeva Vault and ISI Toolbox has further enhanced my ability to deliver high-quality documentation within tight timelines.

As a self-driven and motivated professional, I am passionate about continuous learning and improvement. I thrive in collaborative environments where I can contribute to team objectives and take on new challenges. I am eager to leverage my skills and experience to become a valuable asset in a dynamic organization.

Experience

Work history, roles, and key accomplishments

Current

Senior Biostatistician

Current

Teva Pharmaceuticals

Mar 2014 - Present (11 years 3 months)

Prepared Clinical Study Reports (CSR for Phase I, Phase IV and BA/BE study) within proposed timelines, adhering to raw data and regulatory requirements. Demonstrated knowledge of ICH E3 and ICH GCP E6 guidelines, utilizing Veeva Vault and GRIDS for CTD and eCTD document submissions. Managed eCTD processing, basic medical coding using MedDRA and WHO drug dictionary, and ensured document quality and

Clinical Study Report (CSR)ICH GCP Veeva CTD MedDRA WHO Drug Dictionary Project Management

Medical Writing Associate I

Teva Pharmaceuticals

Nov 2020 - Aug 2023 (2 years 9 months)

Prepared Clinical Study Reports (CSR for Phase I and BA/BE study) within proposed timelines, adhering to raw data and regulatory requirements. Handled preparation and review of aCSR/CSR, Appendices, OGD Tables, Module 2.7, and CS-BE Tables. Managed eCTD processing, prepared Study Protocol, Protocol Clarification letters, Amendments, Informed Consent Forms, and CRFs, and performed basic medical cod

Clinical Study Report (CSR)ACSR CSR Appendices OGD Tables Module 2.7 CS BE Tables Informed Consent Forms MedDRA

Senior Officer-Medical Writer-Clinical

Enem Nostrum Remedies Pvt. Ltd.

Nov 2019 - Nov 2020 (11 months)

Prepared Protocol, Informed Consent Documents (ICD), Case Report Form (CRF), Clinical Study Report, Study Summary Report, and Study updates. Performed OCR and review of eCTD study documents, and prepared SDTM & Clinic tables data with source documents. Resolved facility/study related QA/QC findings and conducted basic medical coding using MedDRA and WHO drug dictionary.

Protocol Preparation Informed Consent Forms Clinical Study Study Summary Report SDTM Clinic Tables QA MedDRA WHO Drug Dictionary

Research Associate- Regulatory Affairs

Accutest Research Laboratories Pvt. Ltd.

Oct 2018 - Nov 2019 (1 year 1 month)

Reviewed projects for submission to regulatory bodies including FDA, ANVISA, NDA, ANDA, EMEA, and in eCTD/ICH format. Prepared and reviewed regulatory submitted documents such as Annex-7, EU m 2.7.1, CSBE-Canada, and DBE summary tables. Prepared and reviewed clinical study reports, and effectively resolved queries from sponsors or regulatory bodies.

Regulatory Affairs FDA ANVISA NDA ANDA Annex 7 EU M 2.7.1 CSBE Canada DBE Summary Table Clinical Study

Senior Clinical Research Associate

LifeSan Clinical Research

May 2016 - Oct 2018 (2 years 5 months)

Managed the receipt, storage, accountability, and dispensing of Investigational Medicinal Products (IMP), including archival/discard after study completion. Prepared protocol, study-specific ICF, CRF, and recruitment flyers. Performed OCR and review of eCTD study documents, acted as BMH/study coordinator, and compiled all essential documents for eCTD submission.

IMP Management Recruitment Flyer BMH Coordinator Clinical Research

Clinical Research Associate

Anazeal Analytical and Research Pvt Ltd.

Dec 2014 - May 2016 (1 year 5 months)

Prepared protocol, ICF, and CRF, and submitted these documents to the Ethics Committee (EC) and sponsor. Prepared trial master files and pre-study checklists, and compiled MSR & other study files. Managed the receipt, storage, handling, accountability, and destruction of investigational product (IP), and was responsible for medication dispensing and IP dosing to subjects.