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Saravanan Palanisamy

@saravananpalanisamy

Manager – Pharmacokinetics at Scitus Pharma Services, leading clinical regulatory document preparation and review and a team of medical writers.

India

Message

At Scitus Pharma Services Pvt Ltd, I lead preparation and review of clinical study protocols, CSRs, investigator brochures, informed consent forms, and CRFs. I also prepare and review eCTD submissions, including CTD Modules 2 and 5.

I perform pharmacokinetic analysis using Phoenix WinNonlin and support SAS statistical programming and code validation. I lead a team of medical writers and coordinate document quality, timelines, and regulatory submissions.

Experience

Work history, roles, and key accomplishments

Current

Manager – Pharmacokinetics

Current

Scitus Pharma Services Pvt Ltd

Jan 2019 - Present (7 years 9 months)

Lead the preparation and review of clinical study protocols, CSRs, IBs, ICFs, and CRFs. Perform pharmacokinetic analysis using Phoenix WinNonlin and support SAS statistical programming and code validation.

Clinical Study Protocols Clinical Study Report (CSR)Investigator Informed Consent Forms eCTD Phoenix WinNonlin (Elementary)SAS ICH GCP Regulatory Compliance SOPs Team Leadership Project Management

Senior Clinical Research Coordinator

Spinos Lifescience and Research Private Limited

Jan 2016 - Dec 2018 (2 years 11 months)

Prepared and reviewed Clinical Study Reports, study protocols, and regulatory submission documents. Coordinated IEC/IRB submissions and performed quality control reviews.

Clinical Study Report (CSR)Protocols Regulatory Submissions IRB IEC Quality Control Mentorship

Clinical Research Associate

Micro Therapeutic Research Labs Private Limited

Jan 2011 - Dec 2016 (5 years 11 months)

Assisted in drafting and reviewing clinical study protocols, ICFs, and CSRs. Conducted scientific literature reviews and supported document formatting and quality control.

Clinical Study Protocols Informed Consent Forms Clinical Study Report (CSR)literature review Quality Control Regulatory Compliance