Medical Safety Expert

Há 5 dias


Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiro
Job Overview

PrimeVigilance is seeking a highly skilled Clinical Review Specialist to join our team. As a Clinical Review Specialist, you will play a vital role in ensuring the safety of patients by reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials.

Responsibilities:
  • Review and approve ICSRs and SAE reports for medical/causality assessment.
  • Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in the medical understanding and evaluation of any safety issues.
  • Review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy.
  • Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings.
  • Cooperate in the preparation of and provide input in Risk Management Plans.
  • Supporting the preparation of responses to regulatory authority requests.
  • Signalling.
  • Reviewing line listings.
  • Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation.
  • Evaluating and categorizing possible signals and proposing a course of action.
  • Supporting preparation and review of benefit-risk reports.

Requirements:
  • The PV Physician should be medically qualified as a physician.
  • Previous experience in pharmacovigilance.
  • Ability to review different aggregate report types including PBRERs and DSURs.
  • Expertise in signal detection activities is essential.
  • Excellent interpersonal skills.
  • Ability to plan, organise, prioritise and execute multiple tasks.
  • Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork.
  • Communication skills.
  • Presentation skills.
  • English - advanced (spoken, written).
  • Advanced literacy (MS Office).

Benefits:
We offer:
  • Training and career development opportunities internally.
  • Strong emphasis on personal and professional growth.
  • Friendly, supportive working environment.
  • Opportunity to work with colleagues based all over the world, with English as the company language.

Estimated Salary: $85,000 - $110,000 per year, depending on location and experience.
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