Pharmacovigilance Specialist

ProductLife Group; Portugal; Presencial; EUR 40 000 - 60 000; Tempo integral

Resumo da oferta

A biotech consulting firm in Portugal seeks a Case Specialist to join their pharmacovigilance team. The role involves providing specialized support in case management, ensuring compliance with regulatory standards, and performing quality control on safety reports. Candidates should have a degree in pharmacy, a minimum of 3 years of pharmacovigilance experience, and proficiency in relevant databases. Strong communication and analytical skills are essential.

Qualificações

• Minimum 3 years of experience in pharmacovigilance, preferably in a service provider setting.
• Proven ability to meet deadlines and manage client communications.
• Strong understanding of pharmacovigilance principles and regulatory frameworks.

Responsabilidades

• Perform QC for post-marketing cases.
• Analyze ICSR download inclusion/exclusion.
• Review and assess safety reports.
• Query and resolve case discrepancies.
• Ensure compliance with GVP, GCP, FDA, and other regulatory requirements.

Conhecimentos

Pharmacovigilance

Client communication

Deadline management

Analytical skills

Formação académica

Degree in Pharmacy

Ferramentas

SafetyEasy database

Microsoft Office

Descrição da oferta de emprego

Overview

PLG supports life sciences companies in achieving smarter compliance through consulting and outsourcing solutions. We are currently seeking a Case Specialist to join our pharmacovigilance team, supporting multi-client case management activities.

Your Mission

As a Case Specialist, you will provide specialized pharmacovigilance support, focusing on the review, assessment, and quality control of safety reports. You will play a key role in ensuring compliance with regulatory standards and supporting the team with expert-level case handling.

Responsibilities

• Perform QC for post-marketing cases
• Analyze ICSR download inclusion/exclusion
• Review and assess safety reports
• Query and resolve case discrepancies
• Ensure compliance with GVP, GCP, FDA, and other regulatory requirements

Qualifications

• Degree in Pharmacy
• Minimum 3 years of experience in pharmacovigilance, preferably in a service provider setting
• Experience with SafetyEasy database
• Proven ability to meet deadlines and manage client communications

Languages

• French (required)
• English (assumed as working language)

Technical Skills

• Proficiency in Microsoft Office
• Strong understanding of pharmacovigilance principles and regulatory frameworks
• Experience with pharmacovigilance databases and QC processes

Bonus Points

• Strong communication and analytical skills
• Emotional intelligence and adaptability
• Reliable, punctual, and well-organized
• Experience working in multicultural teams

Seniority level

• Associate

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Pharmaceutical Manufacturing