Local Contact for Pharmacovigilance with Estonian and English language at IQVIA

Tartu, Tartu Maakond, Estonia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent
3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience
Excellent written and verbal skills in English (min. C1) and Estonian language (min. C2 / native)
In-depth knowledge of applicable global, regional and local regulatory requirements, International Conference on Harmonization (ICH) guidelines, and relevant Standard Operating Procedures (SOPs)
Very good knowledge of the pharmacovigilance legal framework in Estonia
Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
Demonstrate an understanding of compliance and of quality management systems

Responsibilities

Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal products
Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out
Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates
Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; communicate and document project issues to project team members and department management in a timely manner
Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required
Support pharmacovigilance operations as required

Skills

Key technologies and capabilities for this role

PharmacovigilanceRegulatory ComplianceICH GuidelinesRisk ManagementProject ManagementClinical Trial SafetyPost-Marketing SafetyEU QPPVEstonian LanguageEnglish Language

Questions & Answers

Common questions about this position

What work arrangements are available for this role?

The role can be conducted either Home Based / Hybrid / Office based from anywhere in Europe - the choice is yours.

What language skills are required for this position?

Excellent written and verbal skills in English (min. C1) and Estonian language (min. C2 / native) are required.

What education and experience are needed for this job?

A Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent is required, along with 3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety.

What is the salary for this position?

This information is not specified in the job description.

What knowledge areas are essential for strong candidates?

In-depth knowledge of applicable global, regional and local regulatory requirements, ICH guidelines, SOPs, pharmacovigilance legal framework in Estonia, product safety profiles, compliance, and quality management systems are essential.

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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