Medical Reviewer I Lisboa

Company Overview

Prime
Vigilance (part of Ergomed PLC) is a specialised
- size pharmacovigilance service provider established in 2008. We serve pharmaceutical and biotechnology partners worldwide with services in Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. With staff across Europe, North America and Asia, we cover all therapy areas, including medical devices. We invest in employees through excellent training and development, prioritise employee well‑being, and maintain a healthy work‑life balance.

Job Description

Responsibilities include:

• To review and approve post‑marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment, including coding, assessment of seriousness, listedness/expectedness, causality, writing company comment, follow‑up questions and analysis of similar events. Complete all required supporting documentation such as trackers.
• To review literature screening search strategy.
• To review articles to determine if they contain ICSSRs/SAEs related to the relevant medicinal product or other safety‑related findings.
• Reviewing database outputs.
• To review and provide input in Periodic Safety Update Reports.
• To review and provide input in Development Safety Update Reports.
• Participating in signal detection activities, including meetings and writing signal detection reports.
• Proposing a course of action whenever a possible signal is identified.

Qualifications

• Medically qualified as a physician with demonstrated experience in pharmacovigilance.
• Experience in aggregate reports and signal detection is desirable.
• Excellent interpersonal skills.
• Ability to plan, organise, prioritise and execute multiple tasks.
• Ability to work effectively cross‑culturally and cross‑functionally and value teamwork.
• Communication skills.
• Presentation skills.

Additional Information

We prioritise diversity, equity, and inclusion by creating an equal‑opportunity workplace and a human‑centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow. To succeed we must work together with a human‑first approach. We thrive on improving the lives of those around us.

We Offer

• Training and career development opportunities internally.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues worldwide, with English as the company language.

Core Values

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships