Clinical Research Officer

3-4 years

2-5 Lacs P.A.

Nagpur

Openings: 10 Posted: March 4, 2024

Job Description

Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

Share resume at: amol.ingle@cielhr.com

Job description

Role:- Clinical Research Officer

Location: Nagpur (work from office)

3-4 years of experience

Share resume at: amol.ingle@cielhr.com

Role & responsibilities

Job Responsibility: Bioavailability & Bioequivalence (Clinical) Studies

Planning, designing and execution of bioavailability and bioequivalence studies undertaken for international and domestic markets.

Planning and execution of BE studies in India.

CRO identification, selection and budget negotiation.

Review of In vitro Dissolution data (CDP data) for proceeding for the Bioequivalence

study.

Shipment of Investigational Medicinal Product (IMP) to CRO Site for performing the

Bioequivalence/clinical studies.

Review of BE study protocols and Bioanalytical study report, Pharmacokinetic and statistical study report and Clinical study report to ensure its completeness with respect to

scientific and relevant regulatory agency requirements.

Review of Method validation, Bioanalytical study documents and statistical report.

To provide timely response to the queries raised by regulatory authorities after submission of registration dossier and pre-submission queries raised by customer.

Interpretation of available data to recommend suitable study design and approach for the bio studies.

To perform thorough literature search in order to finalize the bio strategy.

To investigate the plausible causes of bio-equivalence failure in order to understand the reason of failure and to provide the opinion on dissolution behavior/study design that

could help us to achieve the success in upcoming bioequivalence study.

Closely worked with formulation development, regulatory affairs and international marketing team.

Preparation and review of Module 2.7.1

Preparation of clinical and nonclinical overview

eCTD Submission of Module 5.

Review of CDISC datasets for USFDA studies.

Job Responsibility: Pharmacovigilance

Overall responsibility of Pharmacovigilance functions.

Collection, evaluation and submission of Individual Case Safety Reports,

Database entry ensuring accuracy and consistency in line with PPPs case processing SOPs.

Preparation & Submission of PSUR reports to regulatory Authorities.

Preparation of Signal Detection Reports and Risk Management Plans.

Implementation and maintenance of Safety Data Exchange Agreements and transmission and reconciliation of Pharmacovigilance data, ensuring compliance with the relevant

legislation.

Literature searching.

Narrative writing.

Role: Clinical research Scientist

Industry Type: Pharmaceutical & Life Sciences

Department: Research & Development

Employment Type: Full Time, Permanent

Role Category: Pharmaceutical & Biotechnology

Education

PG: M.Pharma in Any Specialization, Medical-MS/MD in Any Specialization

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