Clinical Research Doctor/Physician (India)

Clinical Research Doctor/Physician (India)

02 Oct
|
Qinecsa Solutions
|
India

02 Oct

Qinecsa Solutions

India

We are Hiring Medical Safety Physicians/Drug Safety Physicians with 1-3 years of relevant experience as a Medical Reviewer.
Job Title: Medical Safety Physician
Qualifications
Education: MBBS / MD
Mandatory: MCI Registration/State Medical Council Registration
Experience: 1 - 3 years in Pharmacovigilance

Primary Responsibilities

As a medical reviewer

Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Perform triage of cases and determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas




Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Conduct assessment of litigation cases across products as assigned
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned.

Specialized knowledge and skills :
Experience with relevant safety databases and related software applications
Proven experience in customer handling and relationship.
Proven ability to perform task management.
Proven people management skills.
Must have positive presentation skills and the ability to give presentations.
Knowledge of the Life Sciences Industry and life c

📌 Clinical Research Doctor/Physician (India)
🏢 Qinecsa Solutions
📍 India

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