Pharmacovigilance Specialist 2 at IQVIA

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required
Minimum of 3 years of experience in clinical trial safety (equivalent combination of relevant education and experience accepted)
Computer literacy and experience working with Microsoft Office (Word, Excel) required
Knowledge of electronic data capture preferred
Excellent verbal and written communication skills required
Excellent interpersonal and organizational skills required
Ability to work independently, prioritize effectively and work in a matrix team environment required
Ability and willingness to travel domestically and internationally as required; ability to rent automobile
Demonstrates expertise in clinical trial safety, including proficiency in leading complex studies and processing complex safety information
Requires minimal oversight and guidance from Safety Management Manager
Able to independently identify, analyze and problem solve complex issues and trends
Provides mentorship and leadership to other Safety Management staff, sharing knowledge and expertise
Excellent knowledge of clinical research process and medical terminology
Able to express complex ideas
Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute PVG department activities
Able to develop knowledge of the disease under study and discuss simpler aspects with site personnel and colleagues
Able to develop knowledge of protocol, regulatory requirements and company SOPs; familiar with matrix team structure and phases of research
Able to identify and document regulatory non-compliance and any issues involving subject safety
Ability to reason independently to assess and recommend specific solutions in a clinical setting
Attention to detail; able to identify and resolve discrepancies on SAE reports and case report forms
Understands electronic data capture including basic data processing functions

Responsibilities

Performs safety case processing tasks including intake and triage, reviewing incoming safety information for completeness and accuracy, tracking and data entry, writing clinical narratives, generating queries, contacting sites for missing/unclear information, QC of cases, generating regulatory reports, reconciliation, and generating metrics
Serves as Safety Management lead on moderate to large sized studies/programs that are moderate to complex in scope of work with minimal guidance, including all aspects of Safety Management start-up process (e.g., writing Safety Management Plan, developing SAE form)
Attendance at team and client meetings, investigator's meetings, and presentations
Training of staff on safety processes
Ensures compliance with budget, including estimating monthly budget projections; proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager
May assist with bid defenses or other presentations
May mentor and/or train new Safety Management staff
Performs other related duties as assigned or requested by department management

Skills

ICH-GCP

Pharmacovigilance

Safety Case Processing

Clinical Narratives

SAE Reporting

Safety Management Plan

Regulatory Reporting

Data Entry

Query Generation

Reconciliation

Metrics Generation

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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