Senior Associate Medical Director of Pharmacovigilance

Há 6 dias


Lisboa, Lisboa, Portugal TN Portugal Tempo inteiro

Job Description

The Senior Associate Medical Director of Pharmacovigilance will provide medical and scientific expertise on pharmacovigilance services. This role involves participating in all aspects of the Medical Safety activities, including:

  1. Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summary.
  2. Composing, editing, and medically reviewing Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements.

Responsibilities

  • Serving as an internal consultant to pharmacovigilance case processing teams on projects.
  • Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile.

Qualifications

  • A medical degree from an accredited and internationally recognized medical school.
  • Experience in risk management, signal detection, and aggregate reports.


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