Associate Medical Safety Director at IQVIA

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

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 (Req)
Knowledge of clinical trials and pharmaceutical research process (Req)
Ability to establish and meet priorities, deadlines, and objectives (Req)
Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility (Req)
Ability to establish and maintain effective working relationships with coworkers, managers and clients (Req)
A valid medical license, or equivalent, from the country or region in which he/she resides and works (Pref)

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
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
Attend and contribute 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

Skills

Pharmacovigilance

Adverse Event Review

ADR Assessment

AOSE

MedDRA Coding

Safety Data Review

PSUR

DSUR

RMP

REMS

Label Development

DSMB

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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