PK Analyst

Location: Pune, Mumbai - Thane, Bangalore   •   Experience: Senior Level   •   Openings: 1
Apply on Gojobs

Job description

Conduct pharmacokinetic (PK) and pharmacodynamic (PD) data analyses utilizing software such as WinNonlin and NONMEM.
Serve as an active contributor on cross functional project teams, providing expertise as a PK Analyst.
Develop PK Analysis Plans and contribute to the development of Statistical Analysis Plans (SAPs).
Author clinical pharmacology components of key regulatory and clinical documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), briefing documents, and regulatory submissions.
Deliver PK data and analyses to support regulatory communications, meetings, and presentations as required.
Perform quality control (QC) checks of analytical outputs prior to internal review to ensure accuracy and compliance.
Identify, evaluate, and implement process improvements within the pharmacokinetics domain to enhance efficiency and quality.
Must have Skill Set
 Pharmacokinetics (PK) and Pharmacodynamics (PD), Non-compartmental analysis (NCA)