Pv Associate Lazio

Pv Associate
Roma
Lazio, Lazio

Company Description

PrimeVigilance, an Ergomed brand, was established to provide specialized pharmacovigilance services to pharmaceutical and biotechnology companies.

These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK.

The company boasted a 40% growth in its revenues in its last report.

This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.

**Job Description**:

- Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management

- Contributes to achieving company´s goals and objectives

- Works under supervision of more experienced colleague

- Providing support to other activities undertaken by the project team on behalf of the client and the company

- Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):

- Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines

- Performing ICSR follow up

- SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)

- Reconciliation (clinical, partners)

- Product Quality Complaint handling and interaction with Quality Assurance

- Medical Information interaction

- Database Outputs and Reports (including data for monthly reporting to clients)

**Qualifications**:

We expect:

- Interested in pursuing a career in pharmacovigilance

- Fleuncy in English

- Knowledge of additional foreign language is an advantage

- Good IT skills (MS Office)

- People who are excited to learn and contribute to patient safety

- Excellent organization skills with attention to detail

- Excellent interpersonal and communication skills

Additional Information

We offer:

- Full-time position

- Pharmacovigilance and other professional trainings

- Various directions of career development

- Competitive salary and benefits

- Very interesting job within a friendly international (EU) team of young highly educated people