11 June, 2022
Duties and Responsibilities: Pharmacokinetics and Biopharmaceutics
1) Lead Pharmacokinetic team, participate in scientific discussions and contribute to strategies and goals pertaining to bioavailability / bioequivalence (BABE) studies.
2) Prioritize and manage multiple BABE studies with overlapping deadlines.
3) Responsible for identification and selection of Contract Research Organization (CRO) for conducting BABE studies.
4) Planning and execution of prequalification and periodic audit at CRO.
5) Execution of Master Service Agreements (MSA) and confidentiality disclosure agreement (CDA).
6) Participate in BE cost finalization, work order and project contract with CRO for the conduct of BABE studies.
7) Obtaining the yearly product indemnification insurance for all BABE studies to be conducted yearly.
8) Provide inputs on to the budget and PROJECT INITIATION FORM for BABE studies.
9) Literature review, design of BE strategy, protocol synopsis preparation and BE study protocol review.
10) Coordination with CRO for obtaining BE NOC from Director General of India office (DCGI) Delhi or respective zonal office of DCGI.
11) Coordination with CRO for obtaining Institutional / Independent Ethics Committee Approval as the case may be.
12) Coordination with F&D or plant QA for the shipment of investigational products to respective CROs.
13) Interpretation of pharmacokinetics of product and pilot BE data sets.
14) In-vivo In-vitro relationship and correlation (IVIVC/R). Sample size finalization for pivotal BABE study.
15) Review of BABE and clinical study protocol in compliance to the prevailing regulatory guidance.
16) Coordination for planning and execution of Clinical, bio-analytical and report activities of BABE studies at CRO.
17) Planning and execution of study monitoring as per prevailing regulatory guidance and preparation of Monitoring report.
18) Review of Clinical study updates and review of AEs and SAEs during BABE studies.
19) Review and interpretation of pilot & pivotal BABE study data. Review of complete Clinical Study Report (CSR).
20) Submission of Module 5 and relevant section of module 2.7 to regulatory affairs department.
Duties and Responsibilities: Pharmacovigilance (PV)
1) Identification of service provider for PV setup. Audit of the PV service providers. Preparation of PV related SOPs.
2) Review of Pharmacovigilance Master Plan.
3) Review and Tracking of Individual Case Safety Report (ICSRs).
4) Review and tracking of medical information calls received at PV service providers.
5) Tracking and review of Standard Response Letters prepared by PV service partner for intended products.
6) Review of PADER- Periodic Adverse Drug Experience Report prepared by PV service provider.
7) Supports product query related responses. ADR/AEs receipt and collection
8) Coordinate for resolution of regulatory queries with PV service providers.
9) Tracking of POs and payment as per predefined scope of PV services.
Ms. Swati Thorat
Email – firstname.lastname@example.org