Opening for Pharmacokinetics Pharmacodynamics (PK PD) dept @ Inventia Healthcare Limited, Thane
Company: Inventia Healthcare Limited, Thane
Experience: 4-6yrs
Location: Thane
Job Description:
- Literature review and preparation of study related documents.
- Review of study protocol with available literature and regulatory guidance.
- To prepare and arrange all DCGI submission data for study approval.
- Co-ordination of study activities with the cross-functional department and external CROs.
- Provides technical guidance for various studies on various aspects for timely availability of study reports.
- Ensures documentation and filing of study reports received from various CROs.
- Evaluation and selection of new proposed CROs for studies on factors such as compliance to the regulatory requirements, facility, resources, infrastructure of CROs.
- Review and respond to client and regulatory agency queries.
- Reviews and monitors study activities regularly to ensure adherence to set timelines, plans, GCP and GLP norms and regulatory requirements (e.g. ICH, EDQM, US FDA) at CROs.
Contact: asha.mathew@inventiahealthcare.com
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