Sr Medical Safety Advisor 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 experience practicing clinical medicine after award of medical degree. Graduate and/or Residency training can qualify for clinical practice experience (Req)
Two (2) years of pharma experience (Pref)
Sound knowledge of Medicine
In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of Pharmacovigilance - ICSR and Aggregate reports
In-depth knowledge of departmental standard operating procedures

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
Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g., DSUR, RMP, PBRER, ad hoc regulatory reports etc)
Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment
Ensure update of watch list, list of expectedness, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
24 hour medical support as required on assigned projects
Maintain awareness of medical safety-regulatory industry developments
Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable

Skills

Pharmacovigilance

Adverse Event Review

Serious Adverse Events

Analyses of Similar Events

Medical Coding

Causality Assessment

DSUR

RMP

PBRER

Safety Surveillance

Protocol Review

Investigative Brochure Review

CRF Review

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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