Local contact for Pharmacovigilance (LQPPV) at IQVIA

Mexico City, Mexico City, Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life SciencesIndustries

Requirements

Availability on a 24/7 basis to receive calls from the local Health Authority as required
Ability to act as deputy EU-QPPV
Capability to visit Health Authorities facilities based on demand (role otherwise home-based)
Knowledge of local regulatory requirements and changes
Understanding of pharmacovigilance systems, agreements, and systems master files
Ability to work independently within the QPPV role and collaboratively in a team environment remotely and on-site
Awareness of project budgets, scope of work (SOW), and project management tools (files, forms, templates, databases, workflows)

Responsibilities

Develop and prepare pharmacovigilance agreements for assigned customers
Prepare pharmacovigilance systems master files under direct supervision
Act as the contact point for pharmacovigilance inspections and deal directly with Health Authority inspectors during statutory inspections
Ensure business continuity and back-up/deputy coverage in case of absence
Ensure awareness of relevant functions (e.g., regulatory affairs, clinical, QA) within client affiliate organization and promote pharmacovigilance at local country level
Respond fully and promptly to requests from Competent Authorities to evaluate benefits and risks of medicinal products, including sales/prescriptions or post-authorization safety studies
Verify that name and contact details are notified to the Health Authority upon contract commencement
Remain up to date on changes in local regulatory requirements; verify mechanisms for safety reasons and risk management plans
Establish and maintain understanding of each project’s budget and SOW; set up and maintain project materials
Proactively identify issues, propose solutions, and respond promptly to requests
Provide regular reports to project manager on metrics, SOW changes, customer requests/concerns; participate in project review meetings; communicate and document issues timely
Communicate regular monthly updates to the EU QPPV/designee and complete regulatory reports as required
Liaise and coordinate with the MAH’s EU QPPV on PV tasks; notify MAH/EU QPPV of emerging safety signals
Communicate signals with public health implications or benefit-risk profile changes to the Health Authority as Emerging Safety Issues
Maintain awareness of sources/channels for safety information at country level
Ensure processes/systems for collection and timely reporting of safety data
Ensure processes/systems for production and timely submission of periodic reports
Maintain awareness of local literature journals; ensure processes to identify/report relevant safety information
Ensure awareness of evolving safety profiles of medicines approved in country
Ensure awareness and oversight of local risk minimization measures
May get involved with collection, translation, recording, and follow-up of ICSRs and/or other non-ICSR safety information
May support submission of pharmacovigilance reports to authorities (e.g., ICSRs, Periodic Safety Update Reports)

Skills

Pharmacovigilance

EU QPPV

Regulatory Compliance

Risk Management Plans

Health Authority Inspections

Systems Master Files

Project Management

Business Continuity

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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