Sr 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

Pharmaceutical, HealthcareIndustries

Requirements

Bachelor's Degree in life sciences (mandatory)
English Advanced (mandatory)
Up to 5 years of relevant pharmacovigilance experience, inclusive of up to 3 years of specific experience in data entry inside Argus and narrative writing inside case processing activities (mandatory)
In depth knowledge and understanding of applicable ARGUS Safety Database and any other internal/Client applications
In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements
Excellent organizational skills, time management skills, attention to detail and accuracy
Excellent working knowledge of Microsoft Office and web-based applications

Responsibilities

Process safety data in compliance with regulations, SOPs, and project requirements
Perform pharmacovigilance activities: Collect and track Adverse Events (AEs) and endpoint information
Determine event status, enter data into databases, code AEs/products, and write narratives
Conduct literature searches, quality reviews, reconciliation, and case closure
Assess safety data for reportability and ensure timely reporting to regulatory authorities and stakeholders
Maintain project documentation, templates, and workflows
Monitor project metrics, timelines, and deliverables; provide regular updates to management
Ensure compliance with quality standards and project processes
Collaborate with cross-functional teams (clinical, data management, project management) and healthcare professionals
Participate in client communications regarding day-to-day project activities
Train and mentor junior team members; support team development
Contribute to process improvements and efficiency initiatives
Complete all required training and maintain compliance with SOPs
Attend project meetings and provide feedback on operational performance
Perform other duties as assigned
Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines
Provide oversight on small to medium service operational projects and act as mentor to junior members of staff

Skills

Key technologies and capabilities for this role

PharmacovigilanceArgus Safety DatabaseAdverse Event ProcessingData EntryNarrative WritingCase ProcessingLiterature SearchRegulatory ReportingSOP ComplianceQuality ReviewReconciliation

Questions & Answers

Common questions about this position

Is this role remote or home-based?

This is a full-time, regular, 100% home-based role.

What qualifications and experience are required for this position?

A Bachelor's Degree in life sciences is mandatory, along with advanced English proficiency, up to 5 years of relevant pharmacovigilance experience including up to 3 years in Argus data entry and narrative writing, in-depth knowledge of ARGUS Safety Database, regulatory requirements, and excellent organizational skills.

What is the salary or compensation for this role?

This information is not specified in the job description.

Does this role involve mentoring or team leadership?

Yes, the role includes training and mentoring junior team members and providing oversight on small to medium service operational projects.

What makes a strong candidate for this Sr Pharmacovigilance Specialist role?

Candidates with a Bachelor's in life sciences, advanced English, up to 5 years pharmacovigilance experience including 3 years in Argus data entry and narrative writing, deep ARGUS and regulatory knowledge, and strong organizational skills will stand out.

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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