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IQVIA
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Assoc Medical Safety Dir

Assoc Medical Safety Dir

IQVIA

0 years

2 - 3 Lacs

Cochin

Posted:4 days ago| Platform: GlassDoor logo

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Skills Required

pharmacovigilance management marketing content coding processing data reports risk evaluation development strategies support monitoring report capture escalation training combination regulations research flexibility healthcare

Work Mode

On-site

Job Type

Part Time

Job Description

Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.

Essential Functions

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
Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
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
Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
Provide medical oversight for label development, review and change
Provide medical support and attendance at Data Safety Monitoring Board Meetings
Attends and contributes medical safety evaluation on Safety Monitoring Committees
Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
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

Qualifications

Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
Knowledge of clinical trials and pharmaceutical research process
Ability to establish and meet priorities, deadlines, and objectives.
Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
Ability to establish and maintain effective working relationships with coworkers, managers and clients
A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

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IQVIA

Pharmaceuticals / Biotechnology

Durham

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Assoc Medical Safety Dir