Drug Safety Officer

Há 4 dias

Porto, Porto, Portugal Apsida Life Science Tempo inteiro

Position Summary

The PV Lead/Drug Safety Officer is responsible for ensuring that pharmacovigilance and product safety activities within Portugal and assigned Southern European countries are conducted in full compliance with local regulations, global standards, and applicable product vigilance agreements.

This role acts as the main point of contact for local pharmacovigilance and provides oversight, leadership, and operational support across multiple markets.

Key Responsibilities

Pharmacovigilance System Oversight

  • Oversee local pharmacovigilance (PV) operations across Portugal, Spain, Andorra, Italy, San Marino, Vatican City, Greece, and Cyprus.
  • Support the Area Safety Head in providing country-specific information for the European Economic Area (EEA) Pharmacovigilance System Master File.
  • Identify and document non-conformances, lead investigations, and implement corrective and preventive actions (CAPAs).

Safety Management & Reporting

  • Manage safety case processing, reporting, and submissions to local health authorities (e.g., SAE, SUSAR, PSUR, RMP).
  • Ensure timely reconciliation of safety data with internal and external partners.
  • Maintain oversight of literature monitoring for adverse event reporting.
  • Coordinate and ensure compliance in safety training for local employees and stakeholders.
  • Monitor local regulatory changes impacting pharmacovigilance and implement necessary process updates.
  • Support health authority interactions and responses to safety-related queries.

Collaboration & Governance

  • Partner with global, regional, and local safety teams to ensure aligned and compliant PV processes.
  • Contribute to cross-functional projects and provide technical and strategic safety input.
  • Manage vigilance-related contractual clauses and periodic reconciliations with partners and vendors.

Audit & Inspection Readiness

  • Support internal and external audits and health authority inspections.
  • Ensure readiness, manage documentation, and assist in CAPA development and implementation.

Procedural & Business Continuity Responsibilities

  • Develop and maintain local safety procedures in alignment with global policies.
  • Support implementation of business continuity plans to ensure uninterrupted safety oversight.

Qualifications & Experience

Education:

  • Degree in a healthcare or life science discipline (e.g., Pharmacy, Nursing, Medicine, Biology, or equivalent).

Experience:

  • Minimum of 3 years of relevant experience in the pharmaceutical industry within pharmacovigilance or drug safety.
  • Prior experience as a Local Safety Officer in Portugal is highly desirable.
  • Experience working in a regional or multi-country capacity is an advantage.

Skills & Competencies:

  • In-depth knowledge of pharmacovigilance regulations and reporting requirements within Portugal and the EU.
  • Strong understanding of risk management and compliance processes.
  • Excellent organizational, analytical, and communication skills.
  • Ability to build collaborative relationships across functions and geographies.
  • Computer literate with familiarity with safety databases and related IT systems.
  • Fluency in
    Portuguese
    and
    English
    (both written and spoken) is required.

What This Role Offers

  • A strategic position with responsibility across multiple European markets.
  • Opportunity to contribute to patient safety and regulatory excellence.
  • Exposure to cross-functional collaboration in a global safety environment.

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