Pharmacovigilance Specialist (Operations Specialist 2) at IQVIA

Mexico City, Mexico City, Mexico

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Apply knowledge and expertise including complex decision making to review, assess and process Safety data and information across service lines
Recognized as specialist in one or more areas
Thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
Knowledge of applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements
Ability to perform Pharmacovigilance activities including collecting/tracking Adverse Events (AE)/endpoint information, determining initial/update status, database entry, coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure, coordinating translations
Ability to assess Safety data for reportability, track and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups within timelines
Understanding of electronic reporting and regulatory tracking requirements
Ability to read, acknowledge, and comply with IQVIA SOPs and customer SOPs, complete required training timely, and maintain training transcripts
Problem-solving capabilities
Effective communication and liaison skills with managers, stakeholders, functional teams (e.g., project management, clinical, data management), health care professionals (e.g., investigators, medical monitors, site coordinators)

Responsibilities

Process Safety data according to applicable regulations, guidelines, SOPs and project requirements
Perform Pharmacovigilance activities per project requirements: collect/track incoming AE/endpoint information, determine initial/update status, database entry, code AE and Products, write narratives, perform Literature related activities, Quality review, assist with reconciliation, case closure activities, coordinate translations, create/maintain/track cases per timelines
Perform activities related to adjudication as applicable
Assess Safety data for reportability to relevant authorities, track reportable cases, and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in required format
Liaise with relevant stakeholders to facilitate expedited reporting and with manager for regulatory tracking and electronic reporting
Contribute knowledge/expertise or lead assigned deliverables in Safety Publishing, Risk Management, Safety Surveillance, Medical Information or other service lines
Ensure quality, productivity, and delivery standards per project requirements and compliance to all project-related processes
Build positive, collaborative team environment, provide training/mentoring to junior staff, lead by example, assist Operations Manager as backup
Provide technical/process information to Safety Management and operational team on project-specific issues
Provide oversight on operational team status, metrics, productivity, and initiatives
Set up and maintain project files, standard templates, electronic forms, databases, and workflow per project requirements
Establish/maintain effective communications: provide regular feedback to operations team manager/stakeholders on project metrics, out-of-scope work, challenges/issues, successes; give effective feedback to junior team members
Participate or lead trainings across Safety process service offerings; participate in working groups for new initiatives and process efficiencies
Liaise with functional team members (e.g., project management, clinical, data management) and health care professionals (e.g., investigators, medical monitors, site coordinators) to address project issues
Attend project team meetings and provide regular feedback/inputs to Operations team manager on operational project metrics, out-of-scope work, challenges/issues, and successes
Liaise with client in relation to project matters

Skills

Pharmacovigilance

Safety Data Processing

Adverse Event Reporting

Case Processing

Database Entry

Coding

Narrative Writing

Quality Review

Reconciliation

Regulatory Reporting

Risk Management

Safety Surveillance

SOP Compliance

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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