Medical Safety Physician

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 :

Secondary Responsibilities

Additional Skills :