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Provide medical experitise on pharmacovigilance services to all Quintiles divisions as requested. The Medical Safety Advisor participates in all aspects of Medical involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.



RESPONSIBILITIES



Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions

(ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary

Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on

regulatory requirements

Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported rofile

Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

Represent safety and clinical data review findings during client meetings

Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract

Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.

Act as Global Safety Physician or Assistant or Back-up on projects as assigned

Attend project meetings, medical safety team meetings, and client meetings as requested

Ensure coverage for all medical safety deliverables within regulatory or contracted timelines

Provide medical escalation support for medical information projects

Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects

24 hour medical support as required on assigned projects

Maintain awareness of medical-safety-regulatory industry developments >

Medical Safety Advisor

Designation / Job Role : Clinical Researcher
Job Description :
PURPOSE


Provide medical experitise on pharmacovigilance services to all Quintiles divisions as requested. The Medical Safety Advisor participates in all aspects of Medical involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.



RESPONSIBILITIES



Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions

(ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary

Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on

regulatory requirements

Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported rofile

Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

Represent safety and clinical data review findings during client meetings

Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract

Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.

Act as Global Safety Physician or Assistant or Back-up on projects as assigned

Attend project meetings, medical safety team meetings, and client meetings as requested

Ensure coverage for all medical safety deliverables within regulatory or contracted timelines

Provide medical escalation support for medical information projects

Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects

24 hour medical support as required on assigned projects

Maintain awareness of medical-safety-regulatory industry developments
Speciality : Other
Number of Openings : 4
Hiring For : Not Disclosed
Location(s) : Bengaluru/Bangalore
Country : India
Experience : 6 - 11 year(s)
Salary : Not Specified
Date Posted : 24-Feb-2015
Application Deadline : Not Specified
Requirements
Education : MBBS- Medicine
M.S/M.D - Any Specialization
Doctorate Not Required
Candidate Profile : Please refer to the Job description above
Company Profile
Posted By : Mr. DocLynk Admin
Organisation Name : Medigrity
Designation : Administration
Job Reference : Not Specified
 
 
   

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