Pharmacovigilance (Case Processing) Specialist / Portugal Viseu

Pharmacovigilance (Case Processing) Specialist / Portugal
Viseu
Viseu, Viseu District, Portugal

Job description:

The Pharmacovigilance Specialist will be responsible for ensuring the operational delivery of assigned tasks at the project level, with a focus on safety case reporting and the processing of safety case report data. The Specialist may assume the role of Primary or Secondary Project Responsible for the assigned project. The role involves communication with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding potential risks related to operational delivery, quality standards, client relationships, and the company's reputation, as well as addressing ad hoc project tasks and requirements. The Pharmacovigilance Specialist may also contribute to the review and update of internal company procedures.

Key Responsibilities:

• Oversee and manage the workflow of safety case reports, ensuring efficient processing.
• Perform triage on safety case reports to assess priority and necessary actions.
• Review, manage, and file source documentation in compliance with regulatory requirements.
• Process safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review (including causality and expectedness assessments), and reporting requirements evaluation.
• Conduct
  - up activities and manage queries related to safety case reports.
• Execute quality control checks on data entry and case processing to ensure accuracy and compliance.
• Reconcile safety case reports to ensure consistency and completeness of data.
• Prepare line listings to summarize and report on safety case data.

Role Qualifications:

• A minimum of a Bachelor’s Degree in a life sciences field.
• At least 1 year of experience in safety and pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry, or newly graduated with relevant educational background.
• Proficiency in both verbal and written English and Portuguese.
• Strong expertise in MS Office applications.
• Based in Portugal.

 Expected Skills:

• Strong analytical and quantitative
  - solving abilities.
• Highly organized with meticulous attention to detail.
• Ability to work efficiently under pressure and meet tight deadlines.
• Excellent planning, time management, and reporting skills.
• Proven ability to think innovatively and approach challenges with creative solutions.
• Capability to interpret and develop policies, while managing multiple tasks effectively.