PK Analyst
PuneFull Time
PHARMACOKINETICS
PHARMACODYNAMICS
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)
Skills Required
PK Analyst
Pharmaceuticals
Bachelor Degree
Full Time, Permanent
Key Skills
- PHARMACOKINETICS
- PHARMACODYNAMICS
Other Information
GO/JC/2619/2026
Hariharan
