Pharmacovigilance Officer

ZEMIR PHARMA CONSULTING Lda.

Lisboa

Hybrid

EUR 30,000 - 42,000

Full time

45 hours ago
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Benefits offered by this job

Hybrid working environment
Comprehensive training and development
Integration into a fast-growing,未来‑or🏷

Job summary

ZEMIR PHARMA CONSULTING Lda. is seeking a Pharmacovigilance Officer to support client PV services, ensuring regulatory compliance and high-quality deliverables.

The role includes ICSR management, literature reviews, safety reporting, and cross-functional collaboration to uphold PV standards. English fluency and PV experience are required for this position.

Qualifications

  • Master’s degree is preferred.
  • 1–2 years of experience in pharmacovigilance.
  • Fluency in spoken and written English is required.

Responsibilities

  • Managing Individual Case Safety Reports (ICSRs), including processing, follow-up and reporting.
  • Conducting and documenting scientific and medical literature reviews.
  • Supporting the preparation and review of aggregate safety reports.
  • Contributing to signal detection, validation, assessment and management activities.
  • Monitoring pharmacovigilance legislation and regulatory guidance and their impact on processes.
  • Maintaining accurate pharmacovigilance records and documentation.
  • Supporting audits, inspections and reconciliation activities.
  • Collaborating with clients, partners and internal teams on PV matters.

Skills

Fluency in English

Education

Master’s degree in Pharmaceutical Sciences

Job description

Join a Growing, Certified ISO 9001:2015 Company Committed to Excellence

Are you ready to contribute to the sustained growth of a company built on the values of honor, integrity, professional ethics, loyalty, honesty, and courage? Do you thrive in a dynamic environment where your work is valued and appreciated? If so, we’d love to have you on board!

ZEMIR PHARMA CONSULTING

is offering an exciting career opportunity as a:

Pharmacovigilance Officer
Your Role

As a Pharmacovigilance Officer, you will be responsible for supporting the delivery of pharmacovigilance services to our clients, ensuring compliance with applicable regulatory requirements and internal procedures. Your responsibilities will include:

  • Managing Individual Case Safety Reports (ICSRs), including case processing, follow-up and reporting;
  • Conducting and documenting scientific and medical literature reviews;
  • Supporting the preparation and review of aggregate safety reports;
  • Contributing to signal detection, validation, assessment and management activities;
  • Monitoring pharmacovigilance legislation and regulatory guidance and assessing their potential impact on applicable processes, procedures and client activities;
  • Maintaining accurate and complete pharmacovigilance records and documentation;
  • Supporting audits, inspections, reconciliation activities and other pharmacovigilance compliance tasks;
  • Collaborating with clients, partners and internal teams on pharmacovigilance matters.
What we are looking for in your profile
  • A master’s degree in Pharmaceutical Sciences (preferential)
  • 1-2 years of experience in pharmacovigilance
  • Fluency in spoken and written English
What we offer
  • Integration into a fast-growing, future-oriented company
  • Comprehensive training and development opportunities
  • Hybrid working environment

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