Local Compliance Specialist at IQVIA

Wilayah Persekutuan Kuala Lumpur, Malaysia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

BA/BS degree in a health or science related field
3 years of previous Pharmaceutical Industry experience with 2 years of experience within clinical research and development and/or quality assurance
Knowledge of the overall drug development process
Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions (an asset)
Conflict resolution/management and negotiation skills
Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development
Experience with regulatory submissions (an asset)
Experience in R&D process requirements to successfully drive Compliance productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
Demonstrated project leadership skills
Problem solver, strategic thinker, leader and collaborator
Highly committed to quality and compliance
Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service

Responsibilities

Monitor compliance risk and ensure mitigation/remediation actions are defined
Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations
Participate in Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
Collaborate with local and central business partners to facilitate inspections and office audits as needed
Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support and/or regional lead responsibilities such as training, account management, etc
Develop and manage local procedural documents
Execute Trial Master File (TMF) QC checks and On-Site Compliance Monitoring Visits (OSCMVs)
Support operational projects for GCO Compliance
Support onboarding of new hires (degree of support varies by region/country needs)
Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
Provide subject matter expertise and advice regarding SOP, system and GCP questions
Provide guidance and expertise for managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk
Perform impact assessments of new/revised local regulations, guidance and standards
Ensure local intelligence is up to date (e.g., RIACS, T-Race, IRON) to support central functions
Collaborate with Business Quality to support LOC Management Review and local supplier assessments, as appropriate
Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements
Full utilization by timely and accurate time reporting

Skills

GCP

SOP Management

CAPA

QC Checks

TMF

Audit Support

Inspection Readiness

Regulatory Intelligence

QEM

OSCMVs

Vendor Management

QMS

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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