# Local Contact for Pharmacovigilance with Estonian and English language

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Tartu-Estonia/Local-Contact-for-Pharmacovigilance-with-Estonian-and-English-language_R1349976-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_9d82c799-880

## Description

As Local Contact for Pharmacovigilance, you will act as local contact for Pharmacovigilance for customers requiring the services for their product(s). This role can be conducted either Home Based / Hybrid / Office based from anywhere in Europe - the choice is yours.

**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.

**Minimum Required Education and Experience**

- 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.

## Skills

### Required
- Pharmacovigilance
- Regulatory Requirements
- ICH Guidelines
- Standard Operating Procedures
- English
- Estonian

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Tartu-Estonia/Local-Contact-for-Pharmacovigilance-with-Estonian-and-English-language_R1349976-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)