Safety Physician-pharmacovigilance - Hyderabad @ inVentiv International

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Safety Physician-pharmacovigilance - Hyderabad

inVentiv International
2 - 7 years
Pune
5 years ago
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Job Description

JOB SUMMARY

The position is responsible for performing medical review of Individual Case Safety Reports (ICSRs),conducting medical assessement of all safety related data and ensuring medical accuracy of the ICSR narrative, coding and appropriate medical interpretation of all cases.

JOB RESPONSIBILITIES

Performs medical review of adverse events reported for investigational and marketed products.

Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS.

Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment.

Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information.

Identifies, communicates and effectively manages potential safety issues.

Interacts with client's safety/medical personnel as appropriate.

Stays abreast of clinical and drug development information relevant to contracted programs.

Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports,PSURs, PADERs).

Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education.

Assists as a mentor and trainer for other internal safety staff including case processing staff.

Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines.

Performing other duties as assigned by management.

Required Candidate profile

Must hold MBBS / MD Degree
Minimum two(2) years' of Clinical Practice experience in Hospitals / Clinics
Minimum two(2)years' experience in Medical Review
Minimum one year(1) of PV case review experience
Good Communication Skills

Job Classification

Industry: Medical, Healthcare, Hospitals
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time

Education

Under Graduation: Any Graduate in Any Specialization, Graduation Not Required
Post Graduation: Any Postgraduate in Any Specialization, Post Graduation Not Required
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required

Contact Details:

Company: inVentiv International
Location(s): Pune

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Keyskills: medical education clinical practice Medical Reviewer pharmacovigilance psurs aggregate reporting case processing paders mbbs doctor md argus meddra Drug Safety Physician ICSR Syneos Health

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Your name (*)

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Preferred City (* max. 2 w/comma)

Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

I agree with website service terms and conditions

inVentiv International

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You will work alongside the brightest minds to create better, faster, smarter processes...

Safety Physician-pharmacovigilance - Hyderabad @ inVentiv International

Home > Drug Regulatory Affairs / Documentation